Tongue Squamous Cell CarcinomaNCT07466810
Resection and Defect Repair of Oral Cancer Aided by Mixed Reality Technology
A study testing Unreal Engine 5 (UE5)-based Mixed Reality (MR) Technology-assisted Resection of Oral Cancer and Defect Reconstruction and Virtual Surgical Guide Technology-assisted Resection of Oral Cancer and Defect Reconstruction in people with Tongue Squamous Cell Carcinoma and Mixed Reality, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
The objective of this exploratory clinical trial is to apply Unreal Engine 5 (UE5)-based Mixed Reality (MR) technology to achieve real-time stereoscopic visualization of surgical planning, personalized free flap harvest and defect reconstruction, accurate oral cancer resection, and precise morphological and volumetric… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tongue Squamous Cell Carcinoma, Mixed Reality, Virtual Surgical Planning
- What is being tested?
- Unreal Engine 5 (UE5)-based Mixed Reality (MR) Technology-assisted Resection of Oral Cancer and Defect Reconstruction and Virtual Surgical Guide Technology-assisted Resection of Oral Cancer and Defect Reconstruction
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Definite pathological diagnosis of oral cancer before surgery;
- Defects suitable for free flap reconstruction;
- Patients have signed the informed consent form and are willing to cooperate with postoperative follow-up.
Who cannot join
- Poor general condition, evaluated as unable to tolerate surgical treatment.
- -Exclusion Criteria (After Enrollment)
- Subjects who have been enrolled in this trial will be excluded if they meet any of the following conditions:
- Violation of important inclusion criteria;
- Subjects did not receive surgical treatment;
- No observation data after randomization. Withdrawal Criteria Withdrawal of subjects from the trial refers to cases where enrolled subjects are determined by the investigator to withdraw from the trial due to conditions that make it inappropriate to continue the trial. In accordance with the informed consent form, subjects have the right to withdraw from the trial midway. Subjects who do not explicitly propose to withdraw but stop receiving treatment and tests and are lost to follow-up are also considered "withdrawn" (or "lost to follow-up"). The reason for withdrawal should be understood and recorded as much as possible, such as: poor subjective curative effect; inability to tolerate certain adverse reactions; inability to continue participating in the clinical study due to personal reasons; economic factors; or lost to follow-up without stating the reason.
Show all 9Show fewer
- Aggravation or deterioration of the condition during the trial that requires emergency measures; (2) Occurrence of certain comorbidities, complications or special physiological changes in subjects during the trial, making it inappropriate to continue participating in the trial; (3) Voluntary withdrawal by the subject.
- Data Handling of Withdrawn Subjects
- Regardless of the reason, the complete clinical data of subjects who withdraw from the trial shall be retained. For all withdrawn subjects, the trial conclusion form and the reason for withdrawal shall be filled in the case report form (CRF). Generally, there are 6 types of reasons: occurrence of adverse events (including adverse drug reactions and allergic reactions), lack of efficacy (deterioration of condition or occurrence of complications), violation of the trial protocol (including poor compliance), lost to follow-up (including voluntary withdrawal by the patient), termination by the sponsor, or others.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Shanghai
About this study
Official title: Prospective Clinical Study in Resection and Defect Repair of Oral Cancer Aided by Mixed Reality Technology Based on UE5 Engine
The objective of this exploratory clinical trial is to apply Unreal Engine 5 (UE5)-based Mixed Reality (MR) technology to achieve real-time stereoscopic visualization of surgical planning, personalized free flap harvest and defect reconstruction, accurate oral cancer resection, and precise morphological and volumetric matching of the reconstructed free flap to the defect site.
Researchers adopted a parallel controlled design, with participants randomized into three groups: Experimental Group 1 (undergoing Mixed Reality [MR] technology-assisted surgery), Experimental Group 2 (undergoing virtual surgical guide-assisted surgery), and Control Group (undergoing conventional surgery). A total of 30 participants will be recruited, with 10 cases in each group.
The primary purpose is to confirm the effectiveness of MR technology in assisting oral cancer resection, free flap design, harvest, and defect reconstruction. Allocation concealment will be implemented via the sealed envelope method.
Read the detailed description
Study population: Patients with oral cancer confirmed by preoperative pathology (tumor diameter > 3 cm), who had defects suitable for free flap reconstruction, signed written informed consent, agreed to complete postoperative follow-up, and were medically eligible for major surgery. This study was conducted at the Department of Oral and Maxillofacial-Head and Neck Oncology, the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine.
The study is conducted at the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine.
Primary research questions \& outcome assessments:
- Whether UE5-based MR technology enables precise morphological and volumetric matching of free flaps in oral cancer reconstruction.
- Comparisons of operative duration, flap characteristics (utilization, volume, survival), and primary wound healing rate between mixed reality (MR), virtual surgical guide, and conventional surgery.
- Whether MR technology can overcome the limitations of virtual surgical guide systems and further enhance surgical efficiency and precision.
Researchers adopted a parallel controlled design, with participants randomized into three groups: Experimental Group 1 (undergoing Mixed Reality [MR] technology-assisted surgery), Experimental Group 2 (undergoing virtual surgical guide-assisted surgery), and Control Group (undergoing conventional surgery). A total of 30 participants will be recruited, with 10 cases in each group. The primary purpose is to confirm the effectiveness of MR technology in assisting oral cancer resection, free flap design, harvest, and defect reconstruction. Allocation concealment will be implemented via the sealed envelope method.
During the study period, participants will be required to complete the following main tasks and receive relevant interventions:
Preoperatively: Cooperate with computed tomography (CT) data acquisition and complete ultrasonic localization/computed tomography angiography (CTA) examinations (for flap region localization, identification of perforator positions and flap thickness, and corresponding body surface marking). Participants will also collaborate with researchers to design the tumor resection margin, as well as the shape and volume of the free flap to be harvested. After signing the informed consent form, participants will receive surgical treatment corresponding to their randomization assignment.
Intraoperatively: Following the onset of general anesthesia, participants will cooperate with routine surgical skin preparation and draping. For participants in Experimental Group 1, registration and fusion must be completed prior to the initiation of formal surgery to ensure the registration accuracy of MR technology during the operation. In accordance with the preoperative surgical plan, precise tumor resection, free flap harvest, and defect reconstruction will be performed with MR guidance.
Postoperatively: Complete follow-up visits as required, including outpatient follow-ups at 2 weeks ± 3 days, 1 month ± 7 days, 3 months ± 2 weeks, and 6 months ± 1 month postoperatively. Participants will cooperate with physical examinations, CT/magnetic resonance imaging (MRI) scans, and Likert scale assessments, and assist researchers in collecting surgery-related and postoperative recovery data. CT scans will be performed at 1 month and 6 months postoperatively; engineers will import the CT data into a computer, fuse it with the preoperative design scheme, and calculate the morphological similarity (expressed as a percentage).
During the study period, participants must promptly inform researchers if disease progression, complications, or other conditions precluding continued study participation occur. Participants may voluntarily withdraw from the study at any time without affecting their standard medical care.
Participants shall cooperate with researchers in data collection and refrain from participating in other clinical studies or related treatments that may interfere with the results of this study.
- Conditions
- Tongue Squamous Cell Carcinoma, Mixed Reality, Virtual Surgical Planning, Free Flap, Oral Cancer
- Being tested
- Unreal Engine 5 (UE5)-based Mixed Reality (MR) Technology-assisted Resection of Oral Cancer and Defect Reconstruction, Virtual Surgical Guide Technology-assisted Resection of Oral Cancer and Defect Reconstruction
- Keywords
- Mixed Reality, tongue reconstruction, Unreal Engine 5, Glossectomy, Surgical guide, Free Flap, Virtual Surgical Planning, Oral Cancer
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unreal Engine 5 (UE5)-based Mixed Reality (MR) Technology-assisted Resection of Oral Cancer and Defect ReconstructionProcedure or surgery
Intervention Description: Assisted oral cancer resection and defect reconstruction using MR technology based on UE5 engine, to achieve real-time stereoscopic visualization of surgical planning, accurate tumor resection and personalized free flap harvest, ensuring the reconstructed flap matches the defect site in morphology and volume.
Virtual Surgical Guide Technology-assisted Resection of Oral Cancer and Defect ReconstructionProcedure or surgery
Intervention Description: Assisted oral cancer resection and defect reconstruction using virtual surgical guide technology, with surgery performed under the guidance of preoperatively designed and fabricated guides to improve surgical standardization.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Conventional Surgery) | No intervention | Adoption of traditional surgical methods for oral cancer resection and defect repair; no auxiliary technologies such as mixed reality or virtual guides are used, and tumor resection and flap repair are completed relying on the clinician's clinical experience. |
| Experimental Group 1 (Mixed Reality Technology) | Experimental | Application of Mixed Reality (MR) technology based on the UE5 engine to assist in oral cancer resection and defect repair; realize real-time three-dimensional visualization of surgical plans, precise resection of oral cancer, "tailor-made" flap harvesting, and match the shape and volume of the defect site. Receives: Procedure: Unreal Engine 5 (UE5)-based Mixed Reality (MR) Technology-assisted Resection of Oral Cancer and Defect Reconstruction |
| Experimental Group 2 (Virtual Surgical Guide) | Experimental | Application of virtual surgical guide technology to assist in oral cancer resection and defect repair; assist surgery relying on pre-designed and manufactured guides to improve surgical standardization; guide printing is required before surgery, and the plan cannot be adjusted in real time during surgery. Receives: Procedure: Virtual Surgical Guide Technology-assisted Resection of Oral Cancer and Defect Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphological and Volumetric Matching Degree of Free Flap Reconstruction
Description: Computed Tomography (CT) scans will be performed at 1 month and 6 months postoperatively. CT data will be fused with the preoperative design scheme to calculate morphological similarity (expressed as a percentage), so as to evaluate the morphological and volumetric matching effect between the reconstructed flap and the defect site in the three groups. The core purpose is to compare the precision of MR technology with the other two methods.
Measured: Preoperatively 2 weeks ± 3 days postoperatively 1 month ± 7 days postoperatively 3 months ± 2 weeks postoperatively 6 months ± 1 month postoperatively
Secondary outcomes (2)
Surgery-related Indicators
The operative duration and utilization rate of harvested free flaps will be recorded in the three groups to evaluate the impact of different adjuvant technologies on surgical efficiency.
Measured: Preoperatively 2 weeks ± 3 days postoperatively 1 month ± 7 days postoperatively 3 months ± 2 weeks postoperatively 6 months ± 1 month postoperatively
Postoperative Recovery Indicators
The free flap survival rate and primary wound healing rate will be counted in the three groups; the incidence of postoperative complications will be observed to evaluate surgical safety and reconstruction efficacy.
Measured: Preoperatively 2 weeks ± 3 days postoperatively 1 month ± 7 days postoperatively 3 months ± 2 weeks postoperatively 6 months ± 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Tongue Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingming Lv, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- mingming lv, Associate Professor, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466810
- Sponsor's protocol ID
- SH9H-2024-T403-1
- Status last verified
- Mar 2026
- First submitted
- 7 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because the study involves sensitive patient data related to head and neck cancer surgery, including clinical, imaging, and surgical outcome information that could compromise patient privacy and confidentiality if shared. Additionally, the study is still in progress, and premature sharing of IPD may compromise the integrity of the primary analysis and publication plans. Restrictions on IPD sharing are also imposed by the institutional review board (IRB) and ethical guidelines to protect the rights and welfare of study participants, as well as by the data use agreements with participating institutions.
Publications
Joo YH, Hwang SH, Park JO, Cho KJ, Kim MS. Functional outcome after partial glossectomy with reconstruction using radial forearm free flap. Auris Nasus Larynx. 2013 Jun;40(3):303-7. doi: 10.1016/j.anl.2012.07.012. Epub 2012 Aug 10.
PubMed 22884635Chien CY, Su CY, Hwang CF, Chuang HC, Jeng SF, Chen YC. Ablation of advanced tongue or base of tongue cancer and reconstruction with free flap: functional outcomes. Eur J Surg Oncol. 2006 Apr;32(3):353-7. doi: 10.1016/j.ejso.2005.12.010. Epub 2006 Feb 7.
PubMed 16455224Sakuraba M, Asano T, Miyamoto S, Hayashi R, Yamazaki M, Miyazaki M, Ugumori T, Daiko H, Kimata Y. A new flap design for tongue reconstruction after total or subtotal glossectomy in thin patients. J Plast Reconstr Aesthet Surg. 2009 Jun;62(6):795-9. doi: 10.1016/j.bjps.2007.09.056. Epub 2008 Apr 29.
PubMed 18448406Forner D, Phillips T, Rigby M, Hart R, Taylor M, Trites J. Submental island flap reconstruction reduces cost in oral cancer reconstruction compared to radial forearm free flap reconstruction: a case series and cost analysis. J Otolaryngol Head Neck Surg. 2016 Feb 5;45:11. doi: 10.1186/s40463-016-0124-8.
PubMed 26846792Valentini V, Cassoni A, Marianetti TM, Battisti A, Terenzi V, Iannetti G. Anterolateral thigh flap for the reconstruction of head and neck defects: alternative or replacement of the radial forearm flap? J Craniofac Surg. 2008 Jul;19(4):1148-53. doi: 10.1097/SCS.0b013e3181764ad6.
PubMed 18650750Wu JC, Huang JJ, Tsao CK, Abdelrahman M, Kolios G, Cheng MH. Comparison of Posteromedial Thigh Profunda Artery Perforator Flap and Anterolateral Thigh Perforator Flap for Head and Neck Reconstruction. Plast Reconstr Surg. 2016 Jan;137(1):257-266. doi: 10.1097/PRS.0000000000001880.
PubMed 26371390Levine JP, Patel A, Saadeh PB, Hirsch DL. Computer-aided design and manufacturing in craniomaxillofacial surgery: the new state of the art. J Craniofac Surg. 2012 Jan;23(1):288-93. doi: 10.1097/SCS.0b013e318241ba92.
PubMed 22337427Bai S, Shang H, Liu Y, Zhao J, Zhao Y. Computer-aided design and computer-aided manufacturing locating guides accompanied with prebent titanium plates in orthognathic surgery. J Oral Maxillofac Surg. 2012 Oct;70(10):2419-26. doi: 10.1016/j.joms.2011.12.017. Epub 2012 Apr 18. No abstract available.
PubMed 22516840Kumar BP, Venkatesh V, Kumar KA, Yadav BY, Mohan SR. Mandibular Reconstruction: Overview. J Maxillofac Oral Surg. 2016 Dec;15(4):425-441. doi: 10.1007/s12663-015-0766-5. Epub 2015 Apr 19.
PubMed 27833334Chang EI, Boukovalas S, Liu J, Largo RD, Hanasono MM, Garvey PB. Reconstruction of Posterior Mandibulectomy Defects in the Modern Era of Virtual Planning and Three-Dimensional Modeling. Plast Reconstr Surg. 2019 Sep;144(3):453e-462e. doi: 10.1097/PRS.0000000000005954.
PubMed 31461040Foley BD, Thayer WP, Honeybrook A, McKenna S, Press S. Mandibular reconstruction using computer-aided design and computer-aided manufacturing: an analysis of surgical results. J Oral Maxillofac Surg. 2013 Feb;71(2):e111-9. doi: 10.1016/j.joms.2012.08.022. Epub 2012 Nov 17.
PubMed 23164998Deek NFAL, Wei FC. Computer-Assisted Surgery for Segmental Mandibular Reconstruction with the Osteoseptocutaneous Fibula Flap: Can We Instigate Ideological and Technological Reforms? Plast Reconstr Surg. 2016 Mar;137(3):963-970. doi: 10.1097/01.prs.0000479998.49928.71.
PubMed 26910680Koumoullis H, Burley O, Kyzas P. Patient-specific soft tissue reconstruction: an IDEAL stage I report of hemiglossectomy reconstruction and introduction of the PANSOFOS flap. Br J Oral Maxillofac Surg. 2020 Jul;58(6):681-686. doi: 10.1016/j.bjoms.2020.04.017. Epub 2020 Apr 27.
PubMed 32349901
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study in Resection and Defect Repair of Oral Cancer Aided by Mixed Reality Technology Based on UE5 Engine
- ClinicalTrials.gov ID
- NCT07466810
- Acronym / sponsor ID
- SH9H-2024-T403-1
- Conditions
- Tongue Squamous Cell Carcinoma, Mixed Reality, Virtual Surgical Planning, Free Flap, Oral Cancer
- Keywords
- Mixed Reality, tongue reconstruction, Unreal Engine 5, Glossectomy, Surgical guide, Free Flap, Virtual Surgical Planning, Oral Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this exploratory clinical trial is to apply Unreal Engine 5 (UE5)-based Mixed Reality (MR) technology to achieve real-time stereoscopic visualization of surgical planning, personalized free flap harvest and defect reconstruction, accurate oral cancer resection, and precise morphological and volumetric matching of the reconstructed free flap to the defect site.
Researchers adopted a parallel controlled design, with participants randomized into three groups: Experimental Group 1 (undergoing Mixed Reality [MR] technology-assisted surgery), Experimental Group 2 (undergoing virtual surgical guide-assisted surgery), and Control Group (undergoing conventional surgery). A total of 30 participants will be recruited, with 10 cases in each group.
The primary purpose is to confirm the effectiveness of MR technology in assisting oral cancer resection, free flap design, harvest, and defect reconstruction. Allocation concealment will be implemented via the sealed envelope method.
Detailed description
Study population: Patients with oral cancer confirmed by preoperative pathology (tumor diameter > 3 cm), who had defects suitable for free flap reconstruction, signed written informed consent, agreed to complete postoperative follow-up, and were medically eligible for major surgery. This study was conducted at the Department of Oral and Maxillofacial-Head and Neck Oncology, the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine.
The study is conducted at the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine.
Primary research questions \& outcome assessments:
- Whether UE5-based MR technology enables precise morphological and volumetric matching of free flaps in oral cancer reconstruction.
- Comparisons of operative duration, flap characteristics (utilization, volume, survival), and primary wound healing rate between mixed reality (MR), virtual surgical guide, and conventional surgery.
- Whether MR technology can overcome the limitations of virtual surgical guide systems and further enhance surgical efficiency and precision.
Researchers adopted a parallel controlled design, with participants randomized into three groups: Experimental Group 1 (undergoing Mixed Reality [MR] technology-assisted surgery), Experimental Group 2 (undergoing virtual surgical guide-assisted surgery), and Control Group (undergoing conventional surgery). A total of 30 participants will be recruited, with 10 cases in each group. The primary purpose is to confirm the effectiveness of MR technology in assisting oral cancer resection, free flap design, harvest, and defect reconstruction. Allocation concealment will be implemented via the sealed envelope method.
During the study period, participants will be required to complete the following main tasks and receive relevant interventions:
Preoperatively: Cooperate with computed tomography (CT) data acquisition and complete ultrasonic localization/computed tomography angiography (CTA) examinations (for flap region localization, identification of perforator positions and flap thickness, and corresponding body surface marking). Participants will also collaborate with researchers to design the tumor resection margin, as well as the shape and volume of the free flap to be harvested. After signing the informed consent form, participants will receive surgical treatment corresponding to their randomization assignment.
Intraoperatively: Following the onset of general anesthesia, participants will cooperate with routine surgical skin preparation and draping. For participants in Experimental Group 1, registration and fusion must be completed prior to the initiation of formal surgery to ensure the registration accuracy of MR technology during the operation. In accordance with the preoperative surgical plan, precise tumor resection, free flap harvest, and defect reconstruction will be performed with MR guidance.
Postoperatively: Complete follow-up visits as required, including outpatient follow-ups at 2 weeks ± 3 days, 1 month ± 7 days, 3 months ± 2 weeks, and 6 months ± 1 month postoperatively. Participants will cooperate with physical examinations, CT/magnetic resonance imaging (MRI) scans, and Likert scale assessments, and assist researchers in collecting surgery-related and postoperative recovery data. CT scans will be performed at 1 month and 6 months postoperatively; engineers will import the CT data into a computer, fuse it with the preoperative design scheme, and calculate the morphological similarity (expressed as a percentage).
During the study period, participants must promptly inform researchers if disease progression, complications, or other conditions precluding continued study participation occur. Participants may voluntarily withdraw from the study at any time without affecting their standard medical care.
Participants shall cooperate with researchers in data collection and refrain from participating in other clinical studies or related treatments that may interfere with the results of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group (Conventional Surgery) | No intervention | –Adoption of traditional surgical methods for oral cancer resection and defect repair; no auxiliary technologies such as mixed reality or virtual guides are used, and tumor resection and flap repair are completed relying on the clinician's clinical experience. |
| Experimental Group 1 (Mixed Reality Technology) | Experimental | Procedure: Unreal Engine 5 (UE5)-based Mixed Reality (MR) Technology-assisted Resection of Oral Cancer and Defect ReconstructionApplication of Mixed Reality (MR) technology based on the UE5 engine to assist in oral cancer resection and defect repair; realize real-time three-dimensional visualization of surgical plans, precise resection of oral cancer, "tailor-made" flap harvesting, and match the shape and volume of the defect site. |
| Experimental Group 2 (Virtual Surgical Guide) | Experimental | Procedure: Virtual Surgical Guide Technology-assisted Resection of Oral Cancer and Defect ReconstructionApplication of virtual surgical guide technology to assist in oral cancer resection and defect repair; assist surgery relying on pre-designed and manufactured guides to improve surgical standardization; guide printing is required before surgery, and the plan cannot be adjusted in real time during surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Definite pathological diagnosis of oral cancer before surgery;
- Defects suitable for free flap reconstruction;
- Patients have signed the informed consent form and are willing to cooperate with postoperative follow-up.
Key exclusion criteria (9 listed)
- Poor general condition, evaluated as unable to tolerate surgical treatment.
- -Exclusion Criteria (After Enrollment)
- Subjects who have been enrolled in this trial will be excluded if they meet any of the following conditions:
- Violation of important inclusion criteria;
- Subjects did not receive surgical treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unreal Engine 5 (UE5)-based Mixed Reality (MR) Technology-assisted Resection of Oral Cancer and Defect ReconstructionIntervention Description: Assisted oral cancer resection and defect reconstruction using MR technology based on UE5 engine, to achieve real-time stereoscopic visualization of surgical planning, accurate tumor resection and personalized free flap harvest, ensuring the reconstructed flap matches the defect site in morphology and volume. | Procedure or surgery | Experimental Group 1 (Mixed Reality Technology) |
| Virtual Surgical Guide Technology-assisted Resection of Oral Cancer and Defect ReconstructionIntervention Description: Assisted oral cancer resection and defect reconstruction using virtual surgical guide technology, with surgery performed under the guidance of preoperatively designed and fabricated guides to improve surgical standardization. | Procedure or surgery | Experimental Group 2 (Virtual Surgical Guide) |
Primary outcome
Morphological and Volumetric Matching Degree of Free Flap Reconstruction
Time frame: Preoperatively 2 weeks ± 3 days postoperatively 1 month ± 7 days postoperatively 3 months ± 2 weeks postoperatively 6 months ± 1 month postoperatively
Description: Computed Tomography (CT) scans will be performed at 1 month and 6 months postoperatively. CT data will be fused with the preoperative design scheme to calculate morphological similarity (expressed as a percentage), so as to evaluate the morphological and volumetric matching effect between the reconstructed flap and the defect site in the three groups. The core purpose is to compare the precision of MR technology with the other two methods.
2 secondary outcomes
Surgery-related Indicators
Time frame: Preoperatively 2 weeks ± 3 days postoperatively 1 month ± 7 days postoperatively 3 months ± 2 weeks postoperatively 6 months ± 1 month postoperatively
Postoperative Recovery Indicators
Time frame: Preoperatively 2 weeks ± 3 days postoperatively 1 month ± 7 days postoperatively 3 months ± 2 weeks postoperatively 6 months ± 1 month postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Background: PubMed 22884635Joo YH, Hwang SH, Park JO, Cho KJ, Kim MS. Functional outcome after partial glossectomy with reconstruction using radial forearm free flap. Auris Nasus Larynx. 2013 Jun;40(3):303-7. doi: 10.1016/j.anl.2012.07.012. Epub 2012 Aug 10.
- Background: PubMed 16455224Chien CY, Su CY, Hwang CF, Chuang HC, Jeng SF, Chen YC. Ablation of advanced tongue or base of tongue cancer and reconstruction with free flap: functional outcomes. Eur J Surg Oncol. 2006 Apr;32(3):353-7. doi: 10.1016/j.ejso.2005.12.010. Epub 2006 Feb 7.
- Background: PubMed 18448406Sakuraba M, Asano T, Miyamoto S, Hayashi R, Yamazaki M, Miyazaki M, Ugumori T, Daiko H, Kimata Y. A new flap design for tongue reconstruction after total or subtotal glossectomy in thin patients. J Plast Reconstr Aesthet Surg. 2009 Jun;62(6):795-9. doi: 10.1016/j.bjps.2007.09.056. Epub 2008 Apr 29.
- Background: PubMed 26846792Forner D, Phillips T, Rigby M, Hart R, Taylor M, Trites J. Submental island flap reconstruction reduces cost in oral cancer reconstruction compared to radial forearm free flap reconstruction: a case series and cost analysis. J Otolaryngol Head Neck Surg. 2016 Feb 5;45:11. doi: 10.1186/s40463-016-0124-8.
- Background: PubMed 18650750Valentini V, Cassoni A, Marianetti TM, Battisti A, Terenzi V, Iannetti G. Anterolateral thigh flap for the reconstruction of head and neck defects: alternative or replacement of the radial forearm flap? J Craniofac Surg. 2008 Jul;19(4):1148-53. doi: 10.1097/SCS.0b013e3181764ad6.
- Background: PubMed 26371390Wu JC, Huang JJ, Tsao CK, Abdelrahman M, Kolios G, Cheng MH. Comparison of Posteromedial Thigh Profunda Artery Perforator Flap and Anterolateral Thigh Perforator Flap for Head and Neck Reconstruction. Plast Reconstr Surg. 2016 Jan;137(1):257-266. doi: 10.1097/PRS.0000000000001880.
- Background: PubMed 22337427Levine JP, Patel A, Saadeh PB, Hirsch DL. Computer-aided design and manufacturing in craniomaxillofacial surgery: the new state of the art. J Craniofac Surg. 2012 Jan;23(1):288-93. doi: 10.1097/SCS.0b013e318241ba92.
- Background: PubMed 22516840Bai S, Shang H, Liu Y, Zhao J, Zhao Y. Computer-aided design and computer-aided manufacturing locating guides accompanied with prebent titanium plates in orthognathic surgery. J Oral Maxillofac Surg. 2012 Oct;70(10):2419-26. doi: 10.1016/j.joms.2011.12.017. Epub 2012 Apr 18. No abstract available.
- Background: PubMed 27833334Kumar BP, Venkatesh V, Kumar KA, Yadav BY, Mohan SR. Mandibular Reconstruction: Overview. J Maxillofac Oral Surg. 2016 Dec;15(4):425-441. doi: 10.1007/s12663-015-0766-5. Epub 2015 Apr 19.
- Background: PubMed 31461040Chang EI, Boukovalas S, Liu J, Largo RD, Hanasono MM, Garvey PB. Reconstruction of Posterior Mandibulectomy Defects in the Modern Era of Virtual Planning and Three-Dimensional Modeling. Plast Reconstr Surg. 2019 Sep;144(3):453e-462e. doi: 10.1097/PRS.0000000000005954.
- Background: PubMed 23164998Foley BD, Thayer WP, Honeybrook A, McKenna S, Press S. Mandibular reconstruction using computer-aided design and computer-aided manufacturing: an analysis of surgical results. J Oral Maxillofac Surg. 2013 Feb;71(2):e111-9. doi: 10.1016/j.joms.2012.08.022. Epub 2012 Nov 17.
- Background: PubMed 26910680Deek NFAL, Wei FC. Computer-Assisted Surgery for Segmental Mandibular Reconstruction with the Osteoseptocutaneous Fibula Flap: Can We Instigate Ideological and Technological Reforms? Plast Reconstr Surg. 2016 Mar;137(3):963-970. doi: 10.1097/01.prs.0000479998.49928.71.
- Individual participant dataSharing planned: No. IPD will not be shared because the study involves sensitive patient data related to head and neck cancer surgery, including clinical, imaging, and surgical outcome information that could compromise patient privacy and confidentiality if shared. Additionally, the study is still in progress, and premature sharing of IPD may compromise the integrity of the primary analysis and publication plans. Restrictions on IPD sharing are also imposed by the institutional review board (IRB) and ethical guidelines to protect the rights and welfare of study participants, as well as by the data use agreements with participating institutions.
Related trials for Tongue Squamous Cell Carcinoma
Not yet recruitingPhase 1/2
Ficerafusp Alfa, Pembrolizumab, and Stereotactic Body Radiotherapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)
Head and Neck Squamous Cell Carcinoma, HPV-Negative Squamous Cell Carcinoma
RecruitingObservational study
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
Esophageal Cancer, Head and Neck Cancer
Active, not recruitingPhase 3
Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Neck Squamous Cell Carcinoma of Unknown Primary, Recurrent Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 3
A Study Comparing Personalized Radiation Therapy With Standard Radiation Therapy in People With HPV-Positive Throat Cancer
HPV-Related Squamous Cell Carcinoma
RecruitingPhase 1
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas
Bladder Cancer, Squamous Cell Carcinoma of the Lung
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
mingming lv, Associate Professor principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unreal Engine 5 (UE5)-based Mixed Reality (MR) Technology-assisted Resection of Oral Cancer and Defect Reconstruction and Virtual Surgical Guide Technology-assisted Resection of Oral Cancer and Defect Reconstruction in people with Tongue Squamous Cell Carcinoma and Mixed Reality, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mingming Lv (86+13818448654, lvmingming001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphological and Volumetric Matching Degree of Free Flap Reconstruction (time frame: Preoperatively 2 weeks ± 3 days postoperatively 1 month ± 7 days postoperatively 3 months ± 2 weeks postoperatively 6 months ± 1 month postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07466810, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.