CompletedNot Applicable

The Efficacy of Sentimag in Detection of Sentinel Node Biopsy

United Kingdom104 participantsStarted 2016-09-22

Plain-language summary

The aim of this study is to evaluate the Sentimag/Sienna+ System (Sentimag®) in clinical routine practice. On the one hand this allows evaluation of the equivalence of the two techniques. On the other hand this ensures that patients do not experience any possible disadvantages by participating. The hypothesis behind this evaluation is that Sentimag is as efficient as conventional sentinel node mapping. The programme will compare the Sentimag® with the conventional sentinel lymph node detection with radioactive tracer combined with blue dye (in centres using the combined technique) and thereby determine whether the new technique is equivalent to the standard technique for SLNB.

Who can participate

Age range

18 Years

Sex

ALL

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 with primary breast cancer scheduled for Sentinel node biopsy; * Patients who are clinically and radiologically node negative;. * Patients aged ≥18 years at time of consent * Patients are able and willing to give informed consent * Ability and willingness to undertake all scheduled visits and assessments Exclusion Criteria: * Patients who are currently Pregnantcy or lactatingon; * Patients with metastatic cancer; * Subject has a known hypersensitivity to blue dye; * Patients with intolerance or hypersensitivity to iron oxide or dextran compounds;, or to Sienna+ * Patients who have iron overload disease; * Patients who has a pacemaker or other implantable device in the chest wall or shoulder; * Previous axilla surgery, or impaired lymphatic function * Subject is deprived of liberty or under guardianship * Subject is indicated or scheduled for post-operative MRI investigation of the breast

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

Proportion of successful sentinel node biopsies (SLNB, detection rate per patient) with either the magnetic or the standard technique

Timeframe: 6 Months

Trial details

NCT IDNCT02739425

SponsorThe Royal Wolverhampton Hospitals NHS Trust

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2018-05-01

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