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

NCT06713681 | Recruiting DMC

• 1 other identifier: KYLX2024-140
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Cancer; Sentinel Lymph Node; Margins of Excision

Keywords

NIR-II; Trop2; Surgical navigation; Breast Cancer; Sentinel Lymph Node

Outcome Measures

Primary Outcomes (2)

• 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 .

  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.

  1 year

Study Arms (1)

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

Interventions

TTP-ICG incubation solution DIAGNOSTIC_TEST

Fresh breast massed and lymph nodes will be incubated with TTP-ICG with different concentrations and times

TTP-ICG incubation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators plan to enroll 40 female 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 will be incubated with the TTP-ICG solution, and NIR-II fluorescence signals from the tissues will be collected.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yunnan Cancer Hospital: lead
• Affiliated Cancer Hospital of Shantou University Medical College: collaborator

Study Sites (1)

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 39413161 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Margins of Excision

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kangliang Lou, Dcotor, Doctor

CONTACT

86+15158661275; 15158661275@163.com

Jingwen Bai, Doctor, Doctor

CONTACT

86+13411961052; baijingwen666@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: December 3, 2024
• Study Start: May 13, 2024
• Primary Completion: May 13, 2025
• Study Completion: December 31, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)