Sentinel Lymph Node Mapping Using Magtrace and MRI in Healthy Subjects for Potential Use in Melanoma Patients

Study Overview
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Brief Summary
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Sentinel lymph node biopsy (SLNB) is crucial in the management of malignant melanoma treatment and is currently performed by pre-operatively inject a colloid nanomaterial labeled with Technetium (99mTc) as radioactive tracer. Intra-operatively, Patent Blue (PB) will be injected to improve the visualization of the lymphatic tract. However, current pre-operative SLN mapping technique, is associated with disadvantages as radiation exposure for both patients and health care personnel and logistic challenges, because of time constraints due to short half-live time of 99mTc. Superparamagnetic iron oxide (SPIO) is novel, non-radioactive technique using a magnetic tracer (Magtrace® (Endomagnetics Ltd.)) and several studies showed that SPIO is non-inferior to dual tracing with 99mTc and PB in breast cancer patients. SPIO is expected to be non-inferior to dual tracing with 99mTc and PB in melanoma patients. However, further research is needed to demonstrate the use of SPIO in pre-operative Magnetic Resonance Imaging (MRI) scanning. Guidance on pre-operative MRI use is rather limited, though fundamental in the intended research process. Hence, the aim of this subprotocol study, which includes healthy subjects, is to develop a pre-operative MRI protocol for melanoma patients. The acquired knowledge will be used to design a feasibility study, including a larger group of melanoma patients.

Official Title
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Sentinel Lymph Node Mapping With Superparamagnetic Iron Oxide for Melanoma: a Pilot Study in Healthy Participants to Establish an Optimal MRI Workflow Protocol

Conditions
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Melanoma

Intervention / Treatment
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* Diagnostic Test: Sentinel node mapping using MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy participants; Participants should be ≥18 years of age at the time of consent; Participants should be willing to provide informed consent. Exclusion Criteria: Known intolerance/hypersensitivity to iron, dextran compounds or Magtrace® itself; Standard MRI exclusion criteria: Implantable (electrical) devices (e.g. pacemaker, cochlear implants, neurostimulator); Any other metal implants; Claustrophobia; MR-incompatible prosthetic heart valves; Tattoos inked with metallic dye. Participants who refuse to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy participants<br> | Diagnostic Test: Sentinel node mapping using MRI<br>* Sentinel lymph node mapping in melanoma patients using a magnetic tracer and MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPIO dosage in milliliters | SPIO dosage in milliliters will be assessed to develop a pre-operative MRI protocol. Testing will be perform in healthy subjects. | Three weeks | 
| Massage duration in seconds | Massage duration in seconds will be assessed to develop a pre-operative MRI protocol. Testing will be perform in healthy subjects. | Three weeks | 
| Time to artefact appearance in minutes | Time to artefact appearance in minutes will be assessed to develop a pre-operative MRI protocol. Testing will be perform in healthy subjects. | Three weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic tracer, Sentinel lymph node, Melanoma, MRI