Sentinel Node Biopsy using Magnetic Nanoparticles: A prospective multicentre phase II non-randomised clinical trial to compare sentinel node biopsy using magnetic nanoparticles vs. standard technique

Phase 2

Completed

• Conditions: 1) Sentinel Lymph Node metastases in breast cancer patient 2) Cancer in the Sentinel Lymph Node(s); 10006291; 10006295

• Registration Number: NL-OMON40081
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 75

Inclusion Criteria

Patients with breast cancer scheduled for SLNB and who are clinically and radiologically (pre-operative ultrasound normal or indeterminate/abnormal and benign FNA or core biopsy) node negative;Patients available for follow-up for at least 12 months

Exclusion Criteria

Intolerance / hypersensitivity to iron or dextran compounds or Sienna+;Patients who cannot / do not receive radioisotope for SLNB;Patients with an iron overload disease;Patients with pacemakers or other implantable devices in the chest-wall;Intolerance / hypersensitivity to patent blue dye in centres where this is used routinely;Exlusion criteria MRI-subprotocol:;Presence of implantable devices (electronically, magnetically, mechanically activated. E.g: cardioverter defibrillators, cardiac pacemakers);Metallic splinters in the eye;Ferromagnetic haemostatic clips in the central nervous system;Claustrophobia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary end-point: The proportion of sentinel nodes detected (detection rate)<br /><br>with either the standard (patent blue dye and radioisotope; or radioisotope<br /><br>alone) or the new technique (magnetic tracer and hand-held magnetometer).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures: Morbidity from SLNB including lymphoedema,<br /><br>numbness, seroma, cutaneous staining, shoulder stiffness, chronic pain and<br /><br>locoregional recurrence.<br /><br><br /><br>An initial cost-effectiveness evaluation of the new technique will also be<br /><br>performed.<br /><br><br /><br>Outcome measures MRI subprotocol: evaluate the accuracy of MRI for the<br /><br>localisation of the SLN and the detection of metastasis (macro and<br /><br>micrometastases).</p><br>