Oral Squamous Cell Carcinoma (OSCC)NCT07794813
Trop2-targeting NIR-II Molecular Probe for Precision Diagnosis of Oral Cancer
An observational study of Oral Squamous Cell Carcinoma (OSCC) and Diagnosis, run by Yunnan Cancer Hospital at 1 site in China.
Trial summary
Given the morphological and clinical similarities between certain oral malignant neoplasms and benign conditions such as oral ulcerations or inflammatory lesions, the potential for misdiagnosis is significant. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oral Squamous Cell Carcinoma (OSCC), Diagnosis
- What is being tested?
- TTP-ICG incubation solution
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2024to 30 Jan 2027
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators plan to enroll 40 female patients, aged 18 to 75 years, who have been assessed to have resectable oral cancer or oral benign tumor and are scheduled to undergo surgery. During the surgery, the resected tumors will be incubated with the TTP-ICG solution, and NIR-II fluorescence signals from the tissues will be collected.
Who may be able to join
- Age range: 18-75 years old;
- Patients with oral cancer or benign oral tumors who plan to undergo surgical intervention;
- Preoperative coagulation function test was normal; ④ No serious underlying diseases; ⑤ WHO Physical Status Score 0-2 points;
- Sign the informed consent form;
Who cannot join
- Suffering from other invasive malignant tumors;
- Surgery cannot be performed for other serious illnesses; ③ Suffering from mental disorders and unable to sign informed consent forms on their own;
- The subject requests to withdraw from the clinical trial; ⑤ The researchers believe that it is not appropriate for them to continue participating in this clinical trial.
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, 1 recruiting
- Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
Guojun Zhang doctor, 86+18850064298, zhangguojun@kmmu.edu.cn
Yixin Chen, +86 18305902616, 844907195@qq.com
About this study
Official title: Trop2-targeting the Second Near Infrared (NIR-II) Molecular Probe for Precision Diagnosis of Oral Cancer
Given the morphological and clinical similarities between certain oral malignant neoplasms and benign conditions such as oral ulcerations or inflammatory lesions, the potential for misdiagnosis is significant. Currently, histopathological examination via tissue biopsy remains the diagnostic gold standard; however, this approach is inherently invasive and may yield incomplete diagnostic results due to sampling limitations and spatial heterogeneity of the lesion. These challenges underscore the urgent need for the development of simple, non-invasive, cost-effective, and real-time in vivo imaging modalities. To address this, the investigators propose the utilization of a previously developed near-infrared II (NIR-II) fluorescent molecular imaging probe, TTP-ICG, which exhibits high specificity for TROP2, a transmembrane glycoprotein frequently overexpressed in oral squamous cell carcinoma (OSCC). This study will evaluate the diagnostic accuracy of OSCC through localized application of the TROP2-targeted probe via clinical specimens being soaked in TTP-ICG solution. Furthermore, the investigators aim to explore the feasibility of employing a mouth wash-based delivery system for the probe, with the ultimate goal of establishing a precise, minimally invasive, and cost-effective real-time imaging strategy for the early detection and diagnosis of OSCC. Such an approach has the potential to significantly enhance diagnostic precision, improve patient outcomes, and increase survival rates.
Read the detailed description
After participants enrollment, surgical treatment will be administered based on clinical diagnosis and treatment. During the surgery, excised clinical specimens will undergo incubation with TTP-ICG following this specific procedure:
- Preparation of the incubation solution: TTP-ICG will be dissolved in phosphate-buffered saline (PBS) at room temperature in the dark, with varying concentrations (5, 10, 20 μg/mL).
- Incubation of clinical specimens: The freshly excised clinical specimens will be immersed and gently agitated in the incubation solution for 3, 5, or 10 minutes. Subsequently, they will be rinsed with PBST buffer (PBS with Tween 20) for 5 minutes and dried using absorbent paper.
- Acquisition of NIR-II images: NIR-II images and fluorescent intensities will be captured using the "Digital Precision Medicine (DPM)" NIR-II system, optimized with appropriate parameters.
- Pathological diagnosis and data analysis: Hematoxylin and eosin staining, along with immuno-histochemistry, will be performed. The subsequent correlation between pathological characterization and fluorescent information will be further analyzed.
- Conditions
- Oral Squamous Cell Carcinoma (OSCC), Diagnosis
- Being tested
- TTP-ICG incubation solution
- Keywords
- oral suqaremous cell cancer, diagnosis, trop2, NIR-II
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTP-ICG incubation solutionDiagnostic test
Fresh clinical specimens will be incubated with TTP-ICG with different concentrations and times.
| Study group | Role | What they receive |
|---|---|---|
| TTP-ICG incubation | The fresh excision clinical specimens will be completely soaked in the TTP-ICG incubation solution (5, 10, 20 μg/mL) for 3, 5, or 10 min, followed by 5 min of rinsing with PBST buffer and drying with absorbent paper. The NIR-II fluorescence imaging will be then performed under the DPM NIR-II system. And the correlation between pathological characterization and fluorescent information will be further analyzed Receives: Diagnostic Test: TTP-ICG incubation solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIR-II fluorescence intensity of oral cancer, para-cancer tissues, and benign masses after TTP-ICG incubation
NIR-II fluorescence imaging acquisition and intensity analysis was conducted using the Digital Precision Medicine (DPM) NIR-II system. Following initial system parameter calibration and spatial scaling, fluorescence signals were captured and quantitatively analyzed to determine the ability to distinguish oral cancer from paracancerous tissues, as well as benign and malignant oral tumors.
Measured: 1 year
Secondary outcomes (1)
Expression of the Trop-2 in the oral cancer
NIR-II fluorescence intensity of the oral cancer tissues with different Trop-2 expression level after TTP-ICG incubation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start3 Dec 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Squamous Cell Carcinoma (OSCC)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunnan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794813
- Sponsor's protocol ID
- KYLX2024-315
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen W, Zhang Y, Zhang L, Luo X, Yang X, Zhu Y, Wang G, Huang W, Zhang D, Zeng Y, Li R, Guo C, Wang J, Wu Z, Liu N, Zhang G. Intraoperative evaluation of tumor margins using a TROP2 near-infrared imaging probe to enable human breast-conserving surgery. Sci Transl Med. 2024 Oct 16;16(769):eado2461. doi: 10.1126/scitranslmed.ado2461. Epub 2024 Oct 16.
PubMed 39413161
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trop2-targeting the Second Near Infrared (NIR-II) Molecular Probe for Precision Diagnosis of Oral Cancer
- ClinicalTrials.gov ID
- NCT07794813
- Acronym / sponsor ID
- KYLX2024-315
- Conditions
- Oral Squamous Cell Carcinoma (OSCC), Diagnosis
- Keywords
- oral suqaremous cell cancer, diagnosis, trop2, NIR-II
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yunnan Cancer HospitalUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 31 Aug 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.
Given the morphological and clinical similarities between certain oral malignant neoplasms and benign conditions such as oral ulcerations or inflammatory lesions, the potential for misdiagnosis is significant. Currently, histopathological examination via tissue biopsy remains the diagnostic gold standard; however, this approach is inherently invasive and may yield incomplete diagnostic results due to sampling limitations and spatial heterogeneity of the lesion. These challenges underscore the urgent need for the development of simple, non-invasive, cost-effective, and real-time in vivo imaging modalities. To address this, the investigators propose the utilization of a previously developed near-infrared II (NIR-II) fluorescent molecular imaging probe, TTP-ICG, which exhibits high specificity for TROP2, a transmembrane glycoprotein frequently overexpressed in oral squamous cell carcinoma (OSCC). This study will evaluate the diagnostic accuracy of OSCC through localized application of the TROP2-targeted probe via clinical specimens being soaked in TTP-ICG solution. Furthermore, the investigators aim to explore the feasibility of employing a mouth wash-based delivery system for the probe, with the ultimate goal of establishing a precise, minimally invasive, and cost-effective real-time imaging strategy for the early detection and diagnosis of OSCC. Such an approach has the potential to significantly enhance diagnostic precision, improve patient outcomes, and increase survival rates.
Detailed description
After participants enrollment, surgical treatment will be administered based on clinical diagnosis and treatment. During the surgery, excised clinical specimens will undergo incubation with TTP-ICG following this specific procedure:
- Preparation of the incubation solution: TTP-ICG will be dissolved in phosphate-buffered saline (PBS) at room temperature in the dark, with varying concentrations (5, 10, 20 μg/mL).
- Incubation of clinical specimens: The freshly excised clinical specimens will be immersed and gently agitated in the incubation solution for 3, 5, or 10 minutes. Subsequently, they will be rinsed with PBST buffer (PBS with Tween 20) for 5 minutes and dried using absorbent paper.
- Acquisition of NIR-II images: NIR-II images and fluorescent intensities will be captured using the "Digital Precision Medicine (DPM)" NIR-II system, optimized with appropriate parameters.
- Pathological diagnosis and data analysis: Hematoxylin and eosin staining, along with immuno-histochemistry, will be performed. The subsequent correlation between pathological characterization and fluorescent information will be further analyzed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TTP-ICG incubation | – | Diagnostic Test: TTP-ICG incubation solutionThe fresh excision clinical specimens will be completely soaked in the TTP-ICG incubation solution (5, 10, 20 μg/mL) for 3, 5, or 10 min, followed by 5 min of rinsing with PBST buffer and drying with absorbent paper. The NIR-II fluorescence imaging will be then performed under the DPM NIR-II system. And the correlation between pathological characterization and fluorescent information will be further analyzed |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators plan to enroll 40 female patients, aged 18 to 75 years, who have been assessed to have resectable oral cancer or oral benign tumor and are scheduled to undergo surgery. During the surgery, the resected tumors will be incubated with the TTP-ICG solution, and NIR-II fluorescence signals from the tissues will be collected.
Key inclusion criteria (4 listed)
- Age range: 18-75 years old;
Key exclusion criteria (3 listed)
- Suffering from other invasive malignant tumors;
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 |
|---|---|---|
| TTP-ICG incubation solutionFresh clinical specimens will be incubated with TTP-ICG with different concentrations and times. | Diagnostic test | TTP-ICG incubation |
Primary outcome
NIR-II fluorescence intensity of oral cancer, para-cancer tissues, and benign masses after TTP-ICG incubation
Time frame: 1 year
NIR-II fluorescence imaging acquisition and intensity analysis was conducted using the Digital Precision Medicine (DPM) NIR-II system. Following initial system parameter calibration and spatial scaling, fluorescence signals were captured and quantitatively analyzed to determine the ability to distinguish oral cancer from paracancerous tissues, as well as benign and malignant oral tumors.
1 secondary outcome
Expression of the Trop-2 in the oral cancer
Time frame: 1 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 31 Aug 2026.
- Results publication: PubMed 39413161Chen W, Zhang Y, Zhang L, Luo X, Yang X, Zhu Y, Wang G, Huang W, Zhang D, Zeng Y, Li R, Guo C, Wang J, Wu Z, Liu N, Zhang G. Intraoperative evaluation of tumor margins using a TROP2 near-infrared imaging probe to enable human breast-conserving surgery. Sci Transl Med. 2024 Oct 16;16(769):eado2461. doi: 10.1126/scitranslmed.ado2461. Epub 2024 Oct 16.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Squamous Cell Carcinoma (OSCC) and Diagnosis, run by Yunnan Cancer Hospital 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 31 Aug 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 Yixin Chen, postgraduate (86+ 18305902616, 844907195@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIR-II fluorescence intensity of oral cancer, para-cancer tissues, and benign masses after TTP-ICG incubation (time frame: 1 year). 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 NCT07794813, which also lists 1 linked publication.
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 31 Aug 2026.