UnknownNot Applicable

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

China40 participantsStarted 2021-11-01

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

What they're measuring

Diagnosis of lymph node metastasis

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

Trial details

NCT IDNCT05623280

SponsorXiang'an Hospital of Xiamen University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-01

Contact for this trial

Xueqi Fan, MD

19859202604 fanxq@stu.xmu.edu.cn

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