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

Zuyderland Medisch Centrum

Status

Completed

Conditions

Melanoma

Treatments

Diagnostic Test: Sentinel node mapping using MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT05054062

METCZ20210103

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.