Sentinel Node Biopsy using Magnetic Nanoparticles for melanoma

ISRCTN ISRCTN15768185
DOI https://doi.org/10.1186/ISRCTN15768185
Secondary identifying numbers 14011
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

Study designNon-randomised; Interventional; Design type: Diagnosis
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleNode Biopsy using Magnetic Nanoparticles: A prospective multicentre feasibility non-randomised clinical trial for melanoma
Study acronymMELAMAG Trial
Study objectivesThe 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) studiedTopic: National Cancer Research Network; Subtopic: Melanoma; Disease: Melanoma
Intervention1. 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 typeOther
Primary outcome measureDetection 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
Secondary outcome measures1. 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
Overall study start date16/04/2013
Completion date04/03/2018

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 160; UK Sample Size: 130; Description: 30 Patients will be recruited in The Netherlands.First analysis will be performed as per protocol after recruitment of 50 patients
Key inclusion criteria1. 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 criteria1. 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 enrolment16/04/2013
Date of final enrolment04/03/2018

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Great Maze Pond
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

ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

Research organisation

Technology Strategy Board (UK)
Private sector organisation / For-profit companies (industry)
Alternative name(s)
TSB
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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