Magnetic Sentinel Node and Occult Lesion Localisation (MagSNOLL)

ISRCTN	ISRCTN68689512
DOI	https://doi.org/10.1186/ISRCTN68689512
Secondary identifying numbers	14979

Submission date: 10/09/2013
Registration date: 10/09/2013
Last edited: 07/03/2017

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-at-way-of-finding-very-small-breast-cancers-and-sentinel-lymph-nodes-magnoll

Contact information

Mr Muneer Ahmed
Scientific

Bermondsey Wing
Great Maze Pond
London
SE1 9RT
United Kingdom

Phone	+44 207 188 6380
Email	muneer.ahmed@kcl.ac.uk

Study information

Study design	Non-randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
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
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
Study 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(s)	City Road and Hampstead, 17/06/2013, ref: 13/LO/0636
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
Primary outcome measure	Successful sentinel lymph node biopsy and lesion localisation.
Secondary outcome measures	No secondary outcome measures
Overall study start date	07/08/2013
Overall study end date	06/08/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	Planned Sample Size: 50; UK Sample Size: 50
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 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

England
United Kingdom

Study participating centre

Bermondsey Wing

London
SE1 9RT
United Kingdom

Sponsor information

King's College London (UK)
University/education

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

Website	http://www.kcl.ac.uk
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Industry

Endomagnetics Limited (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2015		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

07/03/2017: Publication reference added.