TRACIE: Sentinel Lymph Node Mapping Using Magtrace and MRI in Healthy Subjects for Potential Use in Melanoma Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Healthy participants
|
Diagnostic Test: Sentinel node mapping using MRI
Sentinel lymph node mapping in melanoma patients using a magnetic tracer and MRI
|
Outcome Measures
Primary Outcome Measures
- SPIO dosage in milliliters [Three weeks]
SPIO dosage in milliliters will be assessed to develop a pre-operative MRI protocol. Testing will be perform in healthy subjects.
- Massage duration in seconds [Three weeks]
Massage duration in seconds will be assessed to develop a pre-operative MRI protocol. Testing will be perform in healthy subjects.
- Time to artefact appearance in minutes [Three weeks]
Time to artefact appearance in minutes will be assessed to develop a pre-operative MRI protocol. Testing will be perform in healthy subjects.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy participants;
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Participants should be ≥18 years of age at the time of consent;
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Participants should be willing to provide informed consent.
Exclusion Criteria:
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Known intolerance/hypersensitivity to iron, dextran compounds or Magtrace® itself;
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Standard MRI exclusion criteria:
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Implantable (electrical) devices (e.g. pacemaker, cochlear implants, neurostimulator);
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Any other metal implants;
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Claustrophobia;
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MR-incompatible prosthetic heart valves;
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Tattoos inked with metallic dye.
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Participants who refuse to provide informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zuyderland Medical Center | Sittard | Limburg | Netherlands | 6162BG |
Sponsors and Collaborators
- Zuyderland Medisch Centrum
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- METCZ20210103