Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Mr Bauke Anninga
ORCID ID
Contact details
Great Maze Pond
London
SE1 9RT
United Kingdom
bauke.anninga@gstt.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
14011
Study information
Scientific title
Node Biopsy using Magnetic Nanoparticles: A prospective multicentre feasibility non-randomised clinical trial for melanoma
Acronym
MELAMAG Trial
Study hypothesis
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
12/EE/0522; First MREC approval date 07/02/2013
Study design
Non-randomised; Interventional; Design type: Diagnosis
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase II
Drug names
Primary outcome measure
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
Secondary outcome measures
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
Overall trial start date
16/04/2013
Overall trial end date
04/03/2018
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned 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
Participant 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
Recruitment start date
16/04/2013
Recruitment end date
04/03/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Great Maze Pond
London
SE1 9RT
United Kingdom
Funders
Funder type
Research organisation
Funder name
Technology Strategy Board (UK)
Alternative name(s)
TSB
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United Kingdom
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
Basic results (scientific)
Publication list