Plain English Summary
Magnetic Occult Lesion Localization for the surgical management of non-palpable Breast Cancer: The MOLL trial
The aim of this study is to determine the feasibility of using the Tokyo magnetometer and a magnetic marker for wide localized excision in breast cancer.
North East - York Research Ethics Committee, 04/07/2017, ref: 17/NE/0195
Non-randomised; Interventional; Design type: Treatment, Device, Imaging, Surgery
Primary study design
Secondary study design
Non randomised study
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Specialty: Cancer, Primary sub-specialty: Breast Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasm of breast
There is no randomisation or separate treatment arms, as all participants included in the study follow the same procedure.
On the morning prior to surgery the participant receives an injection with a magnetic marker which is placed into the centre of the non-palpable breast tumour. This is done instead of the standard procedure of inserting a wire used to localise breast tumours as it is no longer required. This procedure takes approximately 15 minutes (identification of the tumour, insertion of the marker and identification of the marker into the tumour).
Participants undergo the wide local excision (WLE) surgery. The surgeon uses a hand-held magnetometer to detect the shortened wire (magnetic marker) and excise the whole tumour. This takes approximately 5 minutes (includes multiple detections during surgery). The surgery is undertaken as usual and the standard x-ray of the excised tissue is also be performed as standard.
Participants are followed-up for one year, which is standard protocol. Participants are assessed to see if the magnetic marker and excision of the breast tumour is successful during surgery. Re-excision rates, cosmetic outcomes and morbidity are assessed post operatively.
Primary outcome measures
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
1. Re-excision rate is assessed by reviewing patient notes post-operatively
2. Excised specimen volumes are assessed by weighting the excised tissue volumes during surgery
3. Cosmetic outcome is assessed by reviewing patient notes post-operatively after 3 months and at 1 year follow-up
4. Morbidity from WLE is assessed by reviewing patient notes post-operatively
Overall trial start date
Overall trial end date
Participant 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
Target number of participants
Planned Sample Size: 20; UK Sample Size: 20
Participant exclusion criteria
1. Known intolerance / hypersensitivity to iron compounds
2. Patients with a pacemaker or other implantable devices in the chest wall
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Research Oncology Third floor Bermondsey Wing Great Maze Pond
Association of Breast Surgery
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal. Additional information such as the protocol is available on request.
IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting