NCT05145829

Exploring an Alternative Pre-operative SLN Mapping Method Using a Magnetic Tracer and MRI for Melanoma Patients

Exploring an Alternative Pre-operative Sentinel Lymph Node Mapping Method Using a Magnetic Tracer and MRI for Melanoma Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Zuyderland Medisch Centrum · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 staff and logistic challenges, because of time constraints due to short half-live time of 99mTc. Superparamagnetic iron oxide (SPIO) is a non-radioactive technique using a magnetic tracer (Magtrace® (Endomagnetics Ltd.)) to identify SLNs. 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 MRI scanning. The primary objective of this study is to evaluate the feasibility and diagnostic accuracy of pre-operative MRI scanning using SPIO compared to lymphoscintigraphy (LS) and single-photon emission computed tomography/computed tomography (SPECT/CT) using 99mTc for identifying SLN status in melanoma patients.

Detailed description

Rationale: 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 staff and logistic challenges, because of time constraints due to short half-live time of 99mTc. Superparamagnetic iron oxide (SPIO) is a non-radioactive technique using a magnetic tracer (Magtrace® (Endomagnetics Ltd.)) to identify SLNs. 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 MRI scanning. Objective: The primary objective of this study is to evaluate the feasibility and diagnostic accuracy of pre-operative MRI scanning using SPIO compared to lymphoscintigraphy (LS) and single-photon emission computed tomography/computed tomography (SPECT/CT) using 99mTc for identifying SLN status in melanoma patients. A secondary objective is to assess the feasibility and diagnostic accuracy of SPIO/magnetometer (Sentimag®, Endomagnetics Ltd.) in comparison with dual trace gold standard (99mTc and PB) in SLN procedures in melanoma patients. Study design: A prospective single-arm feasibility study will be performed at the department of Surgical oncology at Zuyderland Medical Center Sittard, the Netherlands. Study population: Adult patients (≥18 years) with primary melanoma stage I-II and an indication for wide local excision (1 cm) and SLN procedure will be included in the study. Intervention (if applicable): All patients will undergo lymphatic mapping with a SPIO tracer (Magtrace®), 99mTc and PB. Main study parameters/endpoints: The concordance in SLN detection rate (sensitivity and specificity) of SPIO/MRI and LS and SPECT/CT using 99mTc. The concordance in SLN detection rate (sensitivity and specificity) of SPIO/magnetometer and the gold standard dual trace technique using 99mTc/Gamma probe and PB. Additionally, the number of post-injection (skin) reactions, complication and adverse events will be noted.

Conditions

• Melanoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diagnostic Test: Sentinel node mapping using MRI	Sentinel lymph node mapping in melanoma patients using a magnetic tracer and MRI

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2021-12-06
• Last updated: 2023-01-26

Locations

1 site across 1 country: Netherlands