The MOLL trial - Magnetic lesion localisation for breast cancer

ISRCTN	ISRCTN74635349
DOI	https://doi.org/10.1186/ISRCTN74635349
Secondary identifying numbers	35018

Submission date: 31/08/2017
Registration date: 20/09/2017
Last edited: 16/01/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-of-a-new-way-to-find-and-remove-breast-cancer-moll-trial

Contact information

Miss Mirjam Peek
Public

Guy's Hospital
Research Oncology
Third floor Bermondsey Wing
Great Maze Pond
London
SE1 9RT
United Kingdom

ORCID ID	0000-0001-5063-3998
Phone	+44 2071880721
Email	mirjam.peek@gstt.nhs.uk

Study information

Study design	Non-randomised; Interventional; Design type: Treatment, Device, Imaging, Surgery
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Magnetic Occult Lesion Localization for the surgical management of non-palpable Breast Cancer: The MOLL trial
Study acronym	MOLL trial
Study objectives	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(s)	North East - York Research Ethics Committee, 04/07/2017, ref: 17/NE/0195
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/04/2016
Completion date	01/04/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 20; UK Sample Size: 20
Key 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
Key exclusion criteria	1. Known intolerance / hypersensitivity to iron compounds 2. Patients with a pacemaker or other implantable devices in the chest wall
Date of first enrolment	21/09/2017
Date of final enrolment	01/04/2018

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Guy's Hospital

Research Oncology
Third floor Bermondsey Wing
Great Maze Pond
London
SE1 9RT
United Kingdom

Sponsor information

Guy's and St Thomas' NHS Foundation Trust
Hospital/treatment centre

Trust Offices
Guy's Hospital
Great Maze Pond
London
SE1 9RT
England
United Kingdom

"ROR"	https://ror.org/00j161312

Funders

Funder type

Government

Association of Breast Surgery

No information available

Results and Publications

Intention to publish date	01/04/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
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 plan	The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

16/01/2018: Cancer Help UK lay summary link added to plain English summary field
26/10/2017: Internal review.