CompletedPhase 3

Technetium Tc 99m Sulfur Colloid Injection for Tracing Sentinel Nodes in Breast Cancer

China213 participantsStarted 2024-01-02

Plain-language summary

The aim of the study is a prospective multicentre phase-3 study that aims to evaluate the detection rate of sentinel lymph node in patients with breast cancer. To compare the detection rates of Technetium Tc 99m Sulfur Colloid Injection(99mTc-SC) and Mitoxantrone Hydrochloride Injection for Tracing(MHI) for lymphatic tracing in patients with breast cancer.

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

. Able to understand and voluntarily sign a written informed consent.
. Female subjects aged 18-70 years ( including 18 and 70 years ).
. Histologically confirmed diagnosis of invasive breast cancer or primary invasive breast cancer or ductal carcinoma in situ (DCIS) ；
. Clinical stage 1 or 2；
. For subjects undergoing surgical treatment, axillary sentinel lymph node biopsy is part of the surgical plan；
. The axillary lymph nodes were negative by imaging examination or confirmed by fine needle aspiration.

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

Sentinel lymph node detection rate.

Timeframe: During surgery (Day 0 or Day 1))

Trial details

NCT IDNCT07764653

SponsorHTA Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-03

View on ClinicalTrials.gov More Sentinel Nodes trials