Breast CancerNIR-IINCT06713681
Trop2-targeting NIR-II Molecular Probe for Breast Cancer Precise Surgery
An observational study of Breast Cancer and Sentinel Lymph Node, run by Yunnan Cancer Hospital at 1 site in China.
Trial summary
Positive surgical margins are closely associated with local recurrence in breast-conserving surgery (BCS). Meanwhile, accurately assessing sentinel lymph node (SLN) metastasis is crucial for determining the extent of axillary lymph node dissection (ALND) and minimizing complications. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Sentinel Lymph Node, Margins of Excision
- What is being tested?
- TTP-ICG incubation solution
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The investigation involved 48 breast cancer patients and 11 fibroadenoma patients , aged 18 to 75 years, who have been assessed to have resectable breast nodules or masses and are scheduled to undergo surgery. During the surgery, the resected tumors and lymph nodes were incubated with the TTP-ICG solution, and NIR-II fluorescence images from the tissues were collected.
Who may be able to join
- Adult patients between 18-75 years of age
- Female
- Patients presenting with a breast nodule or mass presumed to be resectable on pre-operative assessment
- Good operative candidate
- Subject capable of giving informed consent and participating in the process of consent
Who cannot join
- Patients unable to participate in the consent process
- Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc
- Other conditions that the researcher considers inappropriate to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trop2-targeting the Second Near Infrared (NIR-II) Molecular Probe for the Ex Vivo Evaluation of Breast Cancer Surgical Margin and Lymph Node Metastasis Status
Positive surgical margins are closely associated with local recurrence in breast-conserving surgery (BCS). Meanwhile, accurately assessing sentinel lymph node (SLN) metastasis is crucial for determining the extent of axillary lymph node dissection (ALND) and minimizing complications. Indocyanine green (ICG)-based the second near-infrared (NIR-II) fluorescence imaging offers real-time visualization during surgery, potentially reducing positive margin rates and improving SLN detection, while the specificity remains a challenge. Herein, the investigators will introduce a novel NIR-II probe, TTP-ICG, based on a Trop2-targeting peptide and an approach which enables rapid differentiation between cancer and para-cancer tissue as well as metastatic and normal lymph nodes. In brief, fresh tissues will be soaked in TTP-ICG immediately after resection, and their histological characterization will be determined under NIR-II fluorescence imaging. Pathological confirmation will further validate our approach.
Read the detailed description
After patient enrollment, surgical treatment will be administered based on clinical diagnosis and treatment. During the surgery, excised breast masses or lymph nodes 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 fresh breast masses or lymph nodes: The freshly excised breast masses or lymph nodes 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
- Breast Cancer, Sentinel Lymph Node, Margins of Excision
- Being tested
- TTP-ICG incubation solution
- Keywords
- NIR-II, Trop2, Surgical navigation, Breast Cancer, Sentinel Lymph Node
- Medical subject headings
- Breast Neoplasms, Margins of Excision
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 breast massed and lymph nodes will be incubated with TTP-ICG with different concentrations and times
| Study group | Role | What they receive |
|---|---|---|
| TTP-ICG incubation | The fresh excision breast masses or lymph nodes 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.
Differentiation of breast cancer, para-cancer tissues, and benign masses as well as metastatic and normal lymph nodes
NIR-II fluorescence intensity of breast cancer, para-cancer tissues, and benign masses as well as metastatic and normal lymph nodes after TTP-ICG incubation .
Measured: 1 year
Expression of the Trop-2 in the breast cancer and metastatic lymph nodes
NIR-II fluorescence intensity of the breast cancer tissues and metastatic lymph nodes 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 posted3 Dec 2024
- Study start13 May 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
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 Breast CancerStudies 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yunnan Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Cancer Hospital of Shantou University Medical College
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713681
- Sponsor's protocol ID
- KYLX2024-140
- Acronym
- NIR-II
- Status last verified
- Jun 2025
- First submitted
- 21 Jul 2024
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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 3 Apr 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 the Ex Vivo Evaluation of Breast Cancer Surgical Margin and Lymph Node Metastasis Status
- ClinicalTrials.gov ID
- NCT06713681
- Acronym / sponsor ID
- NIR-II / KYLX2024-140
- Conditions
- Breast Cancer, Sentinel Lymph Node, Margins of Excision
- Keywords
- NIR-II, Trop2, Surgical navigation, Breast Cancer, Sentinel Lymph Node
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Yunnan Cancer HospitalUniversity, hospital or other
- Collaborators
- Affiliated Cancer Hospital of Shantou University Medical College
- Study start
- 13 May 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 3 Dec 2024 (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.
Positive surgical margins are closely associated with local recurrence in breast-conserving surgery (BCS). Meanwhile, accurately assessing sentinel lymph node (SLN) metastasis is crucial for determining the extent of axillary lymph node dissection (ALND) and minimizing complications. Indocyanine green (ICG)-based the second near-infrared (NIR-II) fluorescence imaging offers real-time visualization during surgery, potentially reducing positive margin rates and improving SLN detection, while the specificity remains a challenge. Herein, the investigators will introduce a novel NIR-II probe, TTP-ICG, based on a Trop2-targeting peptide and an approach which enables rapid differentiation between cancer and para-cancer tissue as well as metastatic and normal lymph nodes. In brief, fresh tissues will be soaked in TTP-ICG immediately after resection, and their histological characterization will be determined under NIR-II fluorescence imaging. Pathological confirmation will further validate our approach.
Detailed description
After patient enrollment, surgical treatment will be administered based on clinical diagnosis and treatment. During the surgery, excised breast masses or lymph nodes 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 fresh breast masses or lymph nodes: The freshly excised breast masses or lymph nodes 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 breast masses or lymph nodes 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
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigation involved 48 breast cancer patients and 11 fibroadenoma patients , aged 18 to 75 years, who have been assessed to have resectable breast nodules or masses and are scheduled to undergo surgery. During the surgery, the resected tumors and lymph nodes were incubated with the TTP-ICG solution, and NIR-II fluorescence images from the tissues were collected.
Key inclusion criteria (5 listed)
- Adult patients between 18-75 years of age
- Female
- Patients presenting with a breast nodule or mass presumed to be resectable on pre-operative assessment
- Good operative candidate
- Subject capable of giving informed consent and participating in the process of consent
Key exclusion criteria (3 listed)
- Patients unable to participate in the consent process
- Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc
- Other conditions that the researcher considers inappropriate to participate in the study
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 breast massed and lymph nodes will be incubated with TTP-ICG with different concentrations and times | Diagnostic test | TTP-ICG incubation |
Primary outcome
Differentiation of breast cancer, para-cancer tissues, and benign masses as well as metastatic and normal lymph nodes
Time frame: 1 year
NIR-II fluorescence intensity of breast cancer, para-cancer tissues, and benign masses as well as metastatic and normal lymph nodes after TTP-ICG incubation .
Expression of the Trop-2 in the breast cancer and metastatic lymph nodes
Time frame: 1 year
NIR-II fluorescence intensity of the breast cancer tissues and metastatic lymph nodes with different Trop-2 expression level after TTP-ICG incubation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Background: 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.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Breast Cancer and Sentinel Lymph Node, 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 5 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: finished, as of the sponsor's last update on 3 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Differentiation of breast cancer, para-cancer tissues, and benign masses as well as metastatic and normal lymph nodes (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT06713681, 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 3 Apr 2026.