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This is a Pre-Registered Trial study.

December 4, 2025Open Access

Exploring an alternative pre-operative sentinel lymph node mapping method using a Magnetic tracer and MRI for melanoma patients – SCARLETT study protocol

Key Points

Non-inferiority of SPIO compared to Technetium-99m assessed in melanoma patients with a margin of 5%.
The study enrolls 140 patients at Zuyderland Medical Center, with procedures scheduled in a timely manner.
Magnetic tracer (Magtrace) and MRI could replace traditional radioactive techniques in sentinel lymph node mapping.
Potential benefits include reduced radiation exposure and improved patient comfort during pre-operative procedures.

Abstract

Background: Sentinel lymph node biopsy (SLNB) is important in the management of malignant melanoma and is currently performed by pre-operatively injecting a colloid nanomaterial labeled with Technetium (99mTc). Intra-operatively, Patent Blue (PB) is injected to improve the visualization of the lymphatic tract. However, this technique is associated with disadvantages such as radiation exposure and logistic challenges due to short half-live time of 99mTc. Superparamagnetic iron-oxide (SPIO) is a non-radioactive alternative using a magnetic tracer (Magtrace® (Endomagnetics Ltd.)). Several studies showed that SPIO is non-inferior to 99mTc and PB in breast cancer patients. SPIO is expected to be non-inferior in melanoma patients as well. This study aims to evaluate the non-inferiority of pre-operative MRI scanning using SPIO compared to lymphoscintigraphy (LS) and SPECT/CT using 99mTc for identifying SLN status in melanoma patients. Additionally, the non-inferiority of SPIO/magnetometer (Sentimag®, Endomagnetics Ltd.) in comparison with gold standard (99mTc) will be evaluated for SLN procedures in melanoma patients. Methods: A prospective single-arm non-inferiority study is being performed at the department of surgical oncology at the Zuyderland Medical Center Sittard, the Netherlands. One-hundred-and-forty adult patients with primary melanoma stage I-II with an indication for wide local excision (1 cm) and SLNB will be included. All patients will undergo lymphatic mapping with Magtrace® and 99mTc. The MRI protocol proved to be feasible in the previously conducted pilot study. The MRI protocol will be implemented if it proves to be non-inferior with a margin of 5%. ClinicalTrials.gov number: NCT05145829. Discussion: Elimination of radiation exposure is beneficial for both patients and healthcare personnel. Moreover, logistic challenges will be eliminated as SPIO can be injected several days before surgery, immediately followed by MRI scanning. Scheduled surgeries will not be jeopardized by pre-operative logistics and procedures. It will increase both hospital-oriented productivity, patient-friendliness and comfort as surgical delays are avoided.

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