Artificial Intelligence Analysis of Fluorescence Image to Intraoperatively Detect Metastatic Sentinel Lymph Node.

NCT05623280 | Unknown FDA Drug

• 1 other identifier: Xiang'an Hospital of XMU
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to analysis the fluorescence image of the breast sentinel lymph node (SLN) using Indocyanine green (ICG). Moreover, to investigate whether an artificial intelligence protocol was suitable for identifying metastatic status of SLN during the surgery, and evaluate the diagnosis consistency of the AI technique and pathological examinations for lymph node with and without metastasis.

Conditions

Breast Cancer; Sentinel Lymph Node

Outcome Measures

Primary Outcomes (1)

• Diagnosis of lymph node metastasis

  The lymph node metastasis (LNM) status was determined based on the pathological diagnosis of the surgical specimens.

  Participants will be followed for the duration of hospital stay, an expected average of 3 months

Study Arms (1)

Indocyanine green

Injection around the areola with 2-4 points Indocyanine green with 2ml of 1.25mg/mL; Achieve Intraoperative fluorescence images by Near-Infrared I ( NIR-I ) fluorescence imaging instrument.

Drug: Indocyanine green

Interventions

Indocyanine green DRUG

Injection around the areola with 2-4 points Indocyanine green with 2ml of 1.25mg/mL

Also known as: ICG

Indocyanine green

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: women aged 18-70 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants were recruited from Xiang'An Hospital of Xiamen University, between November 30, 2022, and November 30, 2024.

You may qualify if:

• Patients aged 18-70 years female.
• The preoperative core needle biopsy or open surgical excision biopsy diagnosis as breast cancer.
• No clinical examination of suspicious axillary lymph node-positive.
• Preoperative clinical or radiologic evidence without distant metastases (M0).
• The patient has good compliance with the planned protocol during the study and signed informed consent.

You may not qualify if:

• Pregnancy, breastfeeding.
• Allergy to ICG.
• Former operation or radiotherapy in the axilla or breast or thoracic wall in the same side of breast cancer.
• Psychiatric or cognitive impairment.

Sponsors & Collaborators

• Xiang'an Hospital of Xiamen University: lead

Study Sites (1)

Xiamen Key Laboratory of Endocrine-Related Cancer Precision Medicine

Xiamen, Fujian, 361000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Lymph node

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Xueqi Fan, MD

  School of Medicine, Xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xueqi Fan, MD

CONTACT

19859202604; fanxq@stu.xmu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: November 21, 2022
• Study Start: November 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 28, 2022

Record last verified: 2022-11

Locations

CN (1)