Sentinel Node Biopsy using Magnetic Nanoparticles for melanoma

ISRCTN	ISRCTN15768185
DOI	https://doi.org/10.1186/ISRCTN15768185
Protocol serial number	14011
Sponsor	King's College London (UK)
Funder	Technology Strategy Board (UK)

Submission date: 22/08/2013
Registration date: 22/08/2013
Last edited: 29/08/2013

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

http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-magnetic-tracer-find-most-likely-lymph-nodes-melanoma-spread-melamag

Contact information

Mr Bauke Anninga
Scientific

Great Maze Pond
London
SE1 9RT
United Kingdom

Email	bauke.anninga@gstt.nhs.uk

Study information

Primary study design	Interventional
Study design	Non-randomised; Interventional; Design type: Diagnosis
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
Scientific title	Node Biopsy using Magnetic Nanoparticles: A prospective multicentre feasibility non-randomised clinical trial for melanoma
Study acronym	MELAMAG Trial
Study objectives	The standard Sentinel Lymph Node Biopsy (SLNB) technique (patent blue dye and radioisotope) used in melanoma patients has several drawbacks. The use of radioisotope exposes patients and healthcare workers to radiation, is heavily controlled by legislation (both on the specific training for operators and subsequent disposal of surgical waste), and provides poor pre-operative imaging. The MELAMAG trial evaluates a new technique for SLNB against the standard technique. This new technique uses 2 devices: a intradermal injection of a magnetic tracer (Sienna+) and the use of a hand-held device (a magnetometer, SentiMag) to detect the sentinel node(s) intraoperatively.
Ethics approval(s)	12/EE/0522; First MREC approval date 07/02/2013
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network; Subtopic: Melanoma; Disease: Melanoma
Intervention	1. Ex-vivo MRI: In centres that participate in the ex-vivo MRI sub protocol an ex-vivo MRI scan from the sentinel lymph nodes is performed. 2. Injection magnetic tracer: The magnetic tracer is injected intradermally when the patient is anaesthetized. 3. Pre-operative MRI: In centres that participate in the MRI sub protocol a pre-operative MRI scan is performed after injection of magnetic tracer. 4. Sentinel Lymph Node Biopsy: The sentinel lymph node biopsy procedure is performed with the gamma probe as per normal protocol, in addition to that the hand-held magnetometer is used first to localize sentinel lymph nodes. Follow Up Length: 12 month(s); Study Entry : Registration only
Intervention type	Other
Primary outcome measure(s)	Detection rate with either the standard (blue dye and isotope) or the new technique (magnetic) Timepoint(s): The proportion of sentinel nodes detected (detection rate) with either the standard or the new magnetic technique
Key secondary outcome measure(s)	1. Evaluate surgeon's experience; Timepoint(s): Also to evaluate the surgeon's experience with the SentiMag technique and estimate the number of ope 2. Morbidity from SLNB; Timepoint(s): Morbidity from SLNB including lymphoedema, numbness, seroma, infection, cutaneous staining, chronic 3. MRI Scan; Timepoint(s): To evaluate the accuracy of MRI for the localisation of SLNs
Completion date	04/03/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	160
Key inclusion criteria	1. Patients with primary cutaneous melanoma scheduled for SLNB and who are clinically AJCC stage IB-IIC. 2. Patients available for follow-up for at least 12 months Lower Age Limit 18 years
Key exclusion criteria	1. Intolerance / hypersensitivity to iron or dextran compounds 2. Patients who cannot / do not receive radioisotope for SLNB 3. Patients with pacemakers or other implantable devices in the chest wall 4. Patients who had previous surgery to the likely draining lymph node fields 5. Patients with surgical scars between the primary biopsy site the draining lymph node field that may alter the lymphatic drainage pattern 6. Patients with pre-existing lymphedema at the primary biopsy site, either primary or secondary
Date of first enrolment	16/04/2013
Date of final enrolment	04/03/2018

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Great Maze Pond

London
SE1 9RT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes