Magnetic Seed Localisation of Breast Cancers

NCT02635737 | Completed Results DMC

• 1 other identifier: 2016BR005
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single site, single arm, unblinded safety and feasibility cohort study investigating the use of magnetic marker seeds to localise breast tumours.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Migration of Sentimark Device

  Migration of the device\>10mm between mammograms, clip position \>40mm from target lesion

  1-4 weeks from placement

Secondary Outcomes (5)

• Accuracy of Initial Placement

  within 60 minutes of seed placement

• Percentage Magnetic Markers (Seeds) Within Target Area;

  within 60 minutes of seed placement

• Depth of Marker (Seed)

  within 60 minutes of seed placement

• Number of Seeds Detectable on the Sentimag Detector

  Within 60 minutes of seed placement

• Host Response to Implanted Seed Device

  within 4 weeks of seed placement

Other Outcomes (2)

• Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

  Through study completion, an average of six weeks

• Mastectomy Weight

  At Surgery

Study Arms (1)

Sentimark device placement

EXPERIMENTAL

Sentimark device placed in women having mastectomy surgery

Device: Sentimark

Interventions

Sentimark DEVICE

Placement of a metallic clip with paramagnetic properties for tumour localisation

Sentimark device placement

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study;
• Female, aged 18 years or above;
• Diagnosed with breast cancer (invasive or dcis);
• Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study;
• Undergoing mastectomy breast surgery.

You may not qualify if:

• Patients with a Pacemaker or implanted device;
• Patients requiring an MRI scan prior to surgery;
• Patients with known coagulopathy or receiving anticoagulant medication including warfarin, heparin, clopidogrel or rivaroxaban;
• Patients receiving Neoadjuvant chemotherapy;
• Patients who are pregnant or lactating;
• Patients scheduled for immediate breast reconstruction;
• Patients who have received Sienna (iron oxide) injection in the previous six months;
• Patients with an existing breast haematoma close to the target lesion.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• Endomagnetics Inc: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Mr James Harvey
• Organization: UHSM

james.harvey@uhsm.nhs.uk

01612914436

Study Officials

• James R Harvey, MBBS PhD

  University Hospital of South Manchester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: December 21, 2015
• Study Start: July 6, 2016
• Primary Completion: May 3, 2017
• Study Completion: May 3, 2017
• Last Updated: January 15, 2021
• Results First Posted: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share