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 range

18 Years – 70 Years

Sex

FEMALE

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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