Sentinel Lymph Node Mapping With Superparamagnetic Iron Oxide for Melanoma: a Pilot Study in Healthy Participants to Establish an Optimal MRI Workflow Protocol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- SPIO dosage in milliliters
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
SPIO dosage in milliliters
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
James van Bastelaar
Head of department of Surgery (Surgical Oncologist)
Zuyderland Medisch Centrum