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 range18 Years

SexALL

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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

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