The Efficacy of Sentimag in Detection of Sentinel Node Biopsy

NCT02739425 | Completed DMC

• 1 other identifier: 2015SUR79
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Sentinel Node

Keywords

Sentinel lymph node biopsy (SLNB); Superparamagnetic iron oxide (SPIO) tracer

Outcome Measures

Primary Outcomes (1)

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

  6 Months

Secondary Outcomes (4)

• Detection rate per node

  6 Months

• Malignancy rate: proportion of nodes and patients with a malignant result in the definite pathological analysis.

  6 Months

• Concordance rate: proportion of successful labelling with the standard and new technique per patient and per node

  6 Months

• Malignancy concordance: proportion of successful labelling with the standard and new technique per malignancy positive patients and nodes

  6 Months

Study Arms (1)

Standard Procedure plus use of sentimag

OTHER

Detection of the nodes carried out using the gamma probe and also the sentimag - all patients receive both diagnostic interventions

Device: Sentimag Device

Interventions

Sentimag Device DEVICE

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

Standard Procedure plus use of sentimag

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead
• Sysmex Medical: collaborator

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Raghavan Vidya

  The Royal Wolverhampton NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 15, 2016
• Study Start: September 22, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: June 6, 2019

Record last verified: 2019-04

Locations

GB (1)