Condition category
Cancer
Date applied
31/08/2017
Date assigned
20/09/2017
Last edited
16/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

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

Not specified

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

-

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

Sponsor information

Organisation

Guy's and St Thomas' NHS Foundation Trust

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes

16/10/2017: Internal review.