Chest Wall TumorAICW3DPCWDRSNCT06978075
Artificial Intelligence Combined With 3D-Preformed Chest Wall Defection Reconstruction System in Chest Wall Tumor Surgery
A study testing Chest wall tumor resection by the artificial intelgent assistent in people with Chest Wall Tumor and Reconstruction Surgery, run by Wu Weiming.
Trial summary
Chest wall tumors should be completely resection as much as possible while malignant chest wall tumors should be extensively resection. If not completely resection, it will recur in the short time and affect the patient's survival. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chest Wall Tumor, Reconstruction Surgery
- What is being tested?
- Chest wall tumor resection by the artificial intelgent assistent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 31 Dec 2028
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years old, male or female not limited
- Anesthesia ASA score I-II
- Malignant tumor of soft tissue in the chest
- Malignant tumors of ribs, rib cartilage, and sternum
- Tumors with uncertain or unknown properties of ribs, rib cartilage, and sternum
- Giant benign tumors of ribs, rib cartilage, and sternum
- The preoperative examination results indicate that the tumor has not undergone distant metastasis
- Willing to participate in the research and sign the informed consent form
Who cannot join
- Patients with distant metastasis detected during preoperative examination
- Inoperable tumor
- During the examination, it was discovered that the patient had another type of malignant tumor present
- ECOG 4
- Suffering from active or chronic fungal/bacterial/viral infections
- History of allergy to anesthesia related drugs
- Heart and lung dysfunction, liver and kidney dysfunction, inability to tolerate surgery
- Patients with mental disorders who are unable to cooperate with treatment
About this study
Official title: Research on the Application of Artificial Intelligence (AI) Assisted Chest Wall Tumor Resection Combined With Personalized 3D Preformed Chest Wall Defection Reconstruction System in Chest Wall Tumor Surgery
Chest wall tumors should be completely resection as much as possible while malignant chest wall tumors should be extensively resection. If not completely resection, it will recur in the short time and affect the patient's survival. At present, the surgical resection range mainly relies on preoperative imaging examination and the experience of the surgeon. It lacks precise guidance. This can easily lead to incomplete resection. In addition, the reconstruction materials required for reconstruct the excised chest wall defection are often generated in a standardized manner, lacking intraoperative adjustability. To address this clinical issue, we plan to carry out the research on the application of artificial Intelligence (AI) assisted chest wall tumor resection combined with personalized 3D preformed chest wall defection reconstruction system in chest wall tumor surgery.
Read the detailed description
Chest wall tumors should be completely removed as much as possible while malignant tumors should be extensively resection. Due to the lack of sensitivity of the vast majority of chest wall malignant tumors to current chemotherapy drugs, radiotherapy techniques, and even targeted drugs. If not completely resected, the tumor may recur in the short time and catastrophic consequences may occur. At present, the surgical resection range mainly relies on traditional imaging examinations before surgery and the clinical experience of the surgeon. It lacks precise instrument or equipment guidance. This can easily lead to incomplete surgical resection range. In addition, for the reconstruction materials required to reconstruct the chest wall defection after resection, they are often produced in a standardized manner and need to be adjusted according to the surgical situation. Even with 3D printed titanium alloy materials currently available, there is a possibility that they may not be usable once the lesion area exceeds preoperative assessment. To address this clinical issue, we plan to carry out of the research on the application of artificial intelligence (AI) assisted chest wall tumor research combined with a personalized 3D preformed chest wall defect reconstruction system in chest wall tumor surgery. Data will be imported into a computer to draw a 3D model of the tumor and construct an ideal resection range to ensuring sufficient surgical margins while avoiding damage to important nerve and vascular tissues in the chest. Preformed titanium plates will be prepared based on the calculated resection range and the titanium plates will be detachable assembly components through screws, which can be adjusted at any time according to the surgical situation.
- Conditions
- Chest Wall Tumor, Reconstruction Surgery
- Being tested
- Chest wall tumor resection by the artificial intelgent assistent
- Keywords
- chest wall tumor resection and reconstrucion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest wall tumor resection by the artificial intelgent assistentDevice
we plan to carry out of the research on the application of artificial intelligence (AI) assisted chest wall tumor research combined with a personalized 3D preformed chest wall defect reconstruction system in chest wall tumor surgery. Data will be imported into a computer to draw a 3D model of the tumor and construct an ideal resection range to ensuring sufficient surgical margins while avoiding damage to important nerve and vascular tissues in the chest. Preformed titanium plates will be prepared based on the calculated resection range and the titanium plates will be detachable assembly components through screws, which can be adjusted at any time according to the surgical situation.
| Study group | Role | What they receive |
|---|---|---|
| chest wall tumor | Experimental | Not described Receives: Device: Chest wall tumor resection by the artificial intelgent assistent |
What is being measured
The primary outcome is the main question the study is designed to answer.
the tumor status of surgical margin
Visible tumor residue with naked eye, tumor cells visible under microscope, no tumor cells observed under microscope
Measured: 3 year
Secondary outcomes (1)
Stability after chest wall reconstruction
3D pre formed titanium plates are used for chest wall defect reconstruction. Based on the size and shape of the defect during surgery, suitable titanium plates are selected and fixed with nooses for chest wall defect reconstruction surgery.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest Wall TumorStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wu Weiming
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wu Weiming, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978075
- Sponsor's protocol ID
- 20240910
- Acronym
- AICW3DPCWDRS
- Status last verified
- May 2025
- First submitted
- 11 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Application of Artificial Intelligence (AI) Assisted Chest Wall Tumor Resection Combined With Personalized 3D Preformed Chest Wall Defection Reconstruction System in Chest Wall Tumor Surgery
- ClinicalTrials.gov ID
- NCT06978075
- Acronym / sponsor ID
- AICW3DPCWDRS / 20240910
- Conditions
- Chest Wall Tumor, Reconstruction Surgery
- Keywords
- chest wall tumor resection and reconstrucion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wu WeimingUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 May 2025 (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.
Chest wall tumors should be completely resection as much as possible while malignant chest wall tumors should be extensively resection. If not completely resection, it will recur in the short time and affect the patient's survival. At present, the surgical resection range mainly relies on preoperative imaging examination and the experience of the surgeon. It lacks precise guidance. This can easily lead to incomplete resection. In addition, the reconstruction materials required for reconstruct the excised chest wall defection are often generated in a standardized manner, lacking intraoperative adjustability. To address this clinical issue, we plan to carry out the research on the application of artificial Intelligence (AI) assisted chest wall tumor resection combined with personalized 3D preformed chest wall defection reconstruction system in chest wall tumor surgery.
Detailed description
Chest wall tumors should be completely removed as much as possible while malignant tumors should be extensively resection. Due to the lack of sensitivity of the vast majority of chest wall malignant tumors to current chemotherapy drugs, radiotherapy techniques, and even targeted drugs. If not completely resected, the tumor may recur in the short time and catastrophic consequences may occur. At present, the surgical resection range mainly relies on traditional imaging examinations before surgery and the clinical experience of the surgeon. It lacks precise instrument or equipment guidance. This can easily lead to incomplete surgical resection range. In addition, for the reconstruction materials required to reconstruct the chest wall defection after resection, they are often produced in a standardized manner and need to be adjusted according to the surgical situation. Even with 3D printed titanium alloy materials currently available, there is a possibility that they may not be usable once the lesion area exceeds preoperative assessment. To address this clinical issue, we plan to carry out of the research on the application of artificial intelligence (AI) assisted chest wall tumor research combined with a personalized 3D preformed chest wall defect reconstruction system in chest wall tumor surgery. Data will be imported into a computer to draw a 3D model of the tumor and construct an ideal resection range to ensuring sufficient surgical margins while avoiding damage to important nerve and vascular tissues in the chest. Preformed titanium plates will be prepared based on the calculated resection range and the titanium plates will be detachable assembly components through screws, which can be adjusted at any time according to the surgical situation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chest wall tumor | Experimental | Device: Chest wall tumor resection by the artificial intelgent assistent |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-70 years old, male or female not limited
- Anesthesia ASA score I-II
- Malignant tumor of soft tissue in the chest
- Malignant tumors of ribs, rib cartilage, and sternum
- Tumors with uncertain or unknown properties of ribs, rib cartilage, and sternum
Key exclusion criteria (8 listed)
- Patients with distant metastasis detected during preoperative examination
- Inoperable tumor
- During the examination, it was discovered that the patient had another type of malignant tumor present
- ECOG 4
- Suffering from active or chronic fungal/bacterial/viral infections
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 |
|---|---|---|
| Chest wall tumor resection by the artificial intelgent assistentwe plan to carry out of the research on the application of artificial intelligence (AI) assisted chest wall tumor research combined with a personalized 3D preformed chest wall defect reconstruction system in chest wall tumor surgery. Data will be imported into a computer to draw a 3D model of the tumor and construct an ideal resection range to ensuring sufficient surgical margins while avoiding damage to important nerve and vascular tissues in the chest. Preformed titanium plates will be prepared based on the calculated resection range and the titanium plates will be detachable assembly components through screws, which can be adjusted at any time according to the surgical situation. | Device | chest wall tumor |
Primary outcome
the tumor status of surgical margin
Time frame: 3 year
Visible tumor residue with naked eye, tumor cells visible under microscope, no tumor cells observed under microscope
1 secondary outcome
Stability after chest wall reconstruction
Time frame: 3 year
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 18 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Chest wall tumor resection by the artificial intelgent assistent in people with Chest Wall Tumor and Reconstruction Surgery, run by Wu Weiming.
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 8 inclusion and 8 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 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the tumor status of surgical margin (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2025.