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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients ≥18 years of age at the time of consent; - Histological confirmed melanoma (patient must have primary cutaneous melanoma with Breslow thickness ≥ 0.8-2.0mm with or without ulceration or <0.8mm with ulceration (pT1b - pT2b, AJCC 8th edition)); - Indication for wide local excision (margin 1 cm) and SLN procedure; - Patients should be willing and able to provide informed consent.

Exclusion Criteria:

- Intolerance/hypersensitivity to 99mTc-nanocolloid, PB, iron or dextran compounds; - Iron overload disease; - Pregnant or breast-feeding women; - Previous surrounded lymph node surgery; - Patients with head and neck melanomas; - Standard MRI exclusion criteria; - Implantable (electrical) devices (e.g. pacemaker, cochlear implants, neurostimulator); - Any other metal implants; - Claustrophobia; - MR-incompatible prosthetic heart valves; - Patients who are unable or refuse to provide informed consent.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05145829
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Zuyderland Medisch Centrum
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Melanoma patients

All patients will undergo lymphatic mapping with SPIO, 99mTc and PB.

Interventions

Diagnostic Test: - Diagnostic Test: Sentinel node mapping using MRI

Sentinel lymph node mapping in melanoma patients using a magnetic tracer and MRI

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