Condition category
Cancer
Date applied
10/09/2013
Date assigned
10/09/2013
Last edited
19/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr Muneer Ahmed

ORCID ID

Contact details

Bermondsey Wing
Great Maze Pond
London
SE1 9RT
United Kingdom
muneer.ahmed@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14979

Study information

Scientific title

Magnetic Sentinel Node and Occult Lesion Localisation: A feasibility study using magnetic nanoparticles for sentinel node biopsy and localisation of occult breast cancers

Acronym

MagSNOLL

Study hypothesis

In the UK, breast cancer is the most common cancer in women with over 50,000 newly diagnosed patients in 2010. The implementation of breast screening programmes and diagnostic improvements have resulted in up to 35 percent of breast cancers being clinically nonpalpable on diagnosis. The current gold standard for the treatment of these occult lesions is excision by wire guided localisation (WGL). However, WGL has drawbacks. Alternatives have been introduced, but these rely on radioactive materials which have cost and waste management disadvantages. We have developed a handheld magnetometer (SentiMag, Endomagnetics UK) capable of detecting a magnetic dye (Sienna +, Endomagnetics UK) injected into the breast. This technology has already been successfully applied to sentinel lymph node biopsy (SLNB) and is the subject of an NIHR-adopted, UK multicentre trial (SentiMAG Multicentre Trial; Chief Investigator Michael Douek) in breast cancer. We would like to evaluate the use of the same magnetic dye (Sienna+) for both localisation of nonpalpable breast lesions and concurrent SLNB using the SentiMag handheld magnetometer.

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14979

Ethics approval

City Road and Hampstead, 17/06/2013, ref: 13/LO/0636

Study design

Non-randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

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

Condition

Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast

Intervention

Injection of magnetic dye, Intra-tumoral injection of 0.5 mL magnetic dye (Sienna+)

Follow Up Length: 12 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Successful sentinel lymph node biopsy and lesion localisation; Timepoint(s): 01/08/2014

Secondary outcome measures

No secondary outcome measures

Overall trial start date

07/08/2013

Overall trial end date

06/08/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with operable breast cancer visible on ultrasound and suitable for SLNB 2. Neoadjuvant chemotherapy sub-protocol:
Patients with breast cancer due to undergo neoadjuvant chemotherapy and post-chemotherapy SLNB
3. Target Gender: Female ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 50; UK Sample Size: 50

Participant exclusion criteria

1. Intolerance / hypersensitivity to iron or dextran compounds or Sienna +
2. Patients who cannot / do not receive radioisotope for SLNB
3. Patients with an iron overload disease
4. Patients with pacemakers or other implantable devices in the chestwall

Recruitment start date

07/08/2013

Recruitment end date

06/08/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bermondsey Wing
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Hodgkin Building
New Hunts House
Guy's Campus King's College London
London
SE1 1UL
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk

Funders

Funder type

Industry

Funder name

Endomagnetics Limited (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes