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Search / Trial NCT02739425

The Efficacy of Sentimag in Detection of Sentinel Node Biopsy

Launched by THE ROYAL WOLVERHAMPTON HOSPITALS NHS TRUST · Apr 11, 2016

Trial Information

Current as of May 09, 2025

Completed

Keywords

Sentinel Lymph Node Biopsy (Slnb) Superparamagnetic Iron Oxide (Spio) Tracer

ClinConnect Summary

Sentinel lymph node biopsy (SLNB) is now the standard technique used in breast cancer patients with a clinically and radiologically negative axilla. SLNB for breast cancer was introduced in the 1990s3 and it significantly reduces the morbidity associated with axillary node dissection (ALND) including lymphedema, seroma, numbness, wound infection, reduced shoulder motility, and chronic pain.2 The gold standard for sentinel node detection is the 'combined technique'; using both blue dye and radioisotope injection. After allowing both radioisotope and blue dye to localize in the lymphatic syst...

Gender

ALL

Eligibility criteria

  • 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

About The Royal Wolverhampton Hospitals Nhs Trust

The Royal Wolverhampton Hospitals NHS Trust is a leading healthcare provider in the West Midlands, dedicated to delivering high-quality patient care and advancing medical research through clinical trials. As a prominent NHS trust, it encompasses a range of specialized services across multiple hospitals, focusing on innovation and evidence-based practices. The Trust actively engages in clinical research to enhance treatment options and improve patient outcomes, fostering collaboration among healthcare professionals, researchers, and academic institutions. Committed to patient safety and ethical standards, the Royal Wolverhampton Hospitals NHS Trust plays a pivotal role in advancing healthcare through rigorous clinical trials and research initiatives.

Locations

Wolverhampton, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Raghavan Vidya

Principal Investigator

The Royal Wolverhampton NHS Trust

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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