Trop2-targeting NIR-II Molecular Probe for Breast Cancer Precise Surgery (NIR-II)

March 30, 2026 updated by: Yunnan Cancer Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. 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).
  2. 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.
  3. 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.
  4. 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 Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China, 650118
        • Yunnan Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: TTP-ICG incubation solution
Fresh breast massed and lymph nodes will be incubated with TTP-ICG with different concentrations and times

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yunnan Cancer Hospital

Collaborators

Affiliated Cancer Hospital of Shantou University Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2024

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

June 1, 2025

Study Registration Dates

First Submitted

July 21, 2024

First Submitted That Met QC Criteria

November 27, 2024

First Posted (Actual)

December 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLX2024-140

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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