Trop2-targeting the Second Near Infrared (NIR-II) Molecular Probe for the in Vitro Evaluation of Breast Cancer Surgical Margin and Sentinel Lymph Node Metastasis Status

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Yunnan Cancer Hospital
RECRUITING
Kunming
Contact Information
Primary
Kangliang Lou, Dcotor, Doctor
15158661275@163.com
86+15158661275
Backup
Jingwen Bai, Doctor, Doctor
baijingwen666@126.com
86+13411961052
Time Frame
Start Date: 2024-05-13
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Affiliated Cancer Hospital of Shantou University Medical College
Leads: Yunnan Cancer Hospital

This content was sourced from clinicaltrials.gov