Plain English Summary
Trial website
Contact information
Type
Public
Primary contact
Miss Mirjam Peek
ORCID ID
http://orcid.org/0000-0001-5063-3998
Contact details
Guy's Hospital
Research Oncology
Third floor Bermondsey Wing
Great Maze Pond
London
SE1 9RT
United Kingdom
+44 2071880721
mirjam.peek@gstt.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
35018
Study information
Scientific title
Magnetic Occult Lesion Localization for the surgical management of non-palpable Breast Cancer: The MOLL trial
Acronym
MOLL trial
Study hypothesis
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.
Ethics approval
North East - York Research Ethics Committee, 04/07/2017, ref: 17/NE/0195
Study design
Non-randomised; Interventional; Design type: Treatment, Device, Imaging, Surgery
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Specialty: Cancer, Primary sub-specialty: Breast Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasm of breast
Intervention
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.
Intervention type
Other
Phase
Drug names
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
01/04/2016
Overall trial end date
01/04/2019
Reason abandoned
Eligibility
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
Participant type
Patient
Age group
Adult
Gender
Both
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
21/09/2017
Recruitment end date
01/04/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Guy's Hospital
Research Oncology
Third floor Bermondsey Wing
Great Maze Pond
London
SE1 9RT
United Kingdom
Funders
Funder type
Government
Funder name
Association of Breast Surgery
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
01/04/2019
Participant level data
Not expected to be available
Results - basic reporting
Publication summary