Condition category
Cancer
Date applied
22/08/2013
Date assigned
22/08/2013
Last edited
29/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measures

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

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

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

Funders

Funder type

Research organisation

Funder name

Technology Strategy Board (UK)

Alternative name(s)

TSB

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes