The MOLL trial - Magnetic lesion localisation for breast cancer

Completed

• Conditions: Specialty: Cancer, Primary sub-specialty: Breast Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasm of breast; Cancer; Breast Cancer

• Registration Number: ISRCTN74635349
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-20
• Last Update Posted: 12 February 2018
• Study Completion: 2019-04-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Males/females (18 years or over)
2. A non-palpable breast tumour
3. Visible on ultrasound
4. Suitable for wire guided lesion localisation; 1. Males/females (18 years or over)
2. A non-palpable breast tumour
3. Visible on ultrasound
4. Suitable for wire guided lesion localisation

Exclusion Criteria

1. Known intolerance / hypersensitivity to iron compounds
2. Patients with a pacemaker or other implantable devices in the chest wall; 1. Known intolerance / hypersensitivity to iron compounds
2. Patients with a pacemaker or other implantable devices in the chest wall

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful localization of a magnetic marker and excision of the breast tumour is assessed using a magnetic marker and magnetometer during surgery.;Successful localization of a magnetic marker and excision of the breast tumour is assessed using a magnetic marker and magnetometer during surgery.

Secondary Outcome Measures

Name	Time	Method
1. Re-excision rate is assessed by reviewing patient notes post-operatively<br>2. Excised specimen volumes are assessed by weighting the excised tissue volumes during surgery<br>3. Cosmetic outcome is assessed by reviewing patient notes post-operatively after 3 months and at 1 year follow-up<br>4. Morbidity from WLE is assessed by reviewing patient notes post-operatively<br>;1. Re-excision rate is assessed by reviewing patient notes post-operatively<br>2. Excised specimen volumes are assessed by weighting the excised tissue volumes during surgery<br>3. Cosmetic outcome is assessed by reviewing patient notes post-operatively after 3 months and at 1 year follow-up<br>4. Morbidity from WLE is assessed by reviewing patient notes post-operatively<br>