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
Contact information
Mr Bauke Anninga
Scientific
Scientific
Great Maze Pond
London
SE1 9RT
United Kingdom
| bauke.anninga@gstt.nhs.uk |
Study information
| Study design | Non-randomised; Interventional; Design type: Diagnosis |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 16/04/2013 |
| Completion date | 04/03/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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 |
| 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
- England
- United Kingdom
Study participating centre
Great Maze Pond
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
Hodgkin Building
New Hunts House
Guy's Campus King's College London
London
SE1 1UL
England
United Kingdom
"ROR" |
https://ror.org/0220mzb33 |
|---|
Funders
Funder type
Research organisation
Technology Strategy Board (UK)
Private sector organisation / For-profit companies (industry)
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 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? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
