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

Melanoma Clinical Trial

— SCARLETT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05145829
• Other study ID #: METCZ20210156
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: January 2023
• Source: Zuyderland Medisch Centrum
• Contact: James van Bastelaar, MD, PhD
• Phone: 0884597777
• Email: j.vanbastelaar[@]zuyderland.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Diagnostic Test:
• Diagnostic Test: Sentinel node mapping using MRI
Sentinel lymph node mapping in melanoma patients using a magnetic tracer and MRI

Locations

Country	Name	City	State
Netherlands	Zuyderland Medical Center	Sittard	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnostic accuracy of SPIO/MRI and LS+SPECT/CT and 99mTc to identify SLN	The diagnostic accuracy of SPIO/MRI and LS+SPECT/CT and 99mTc to identify SLN will be expressed as sensitivity and specificity, and positive and negative predictive values, including their 95% exact binomial confidence intervals. MRI image analyses will be performed by two independent professionals.	Before surgery (MRI scanning and scintigraphy)
Secondary	The diagnostic accuracy of SPIO/magnetometer and PB, 99mTc and Gamma probe	The diagnostic accuracy of SPIO/magnetometer and PB, 99mTc and Gamma probe will be expressed as sensitivity and specificity, and positive and negative predictive values, including their 95% exact binomial confidence intervals .	During SLNB (surgery)
Secondary	Comparison between 99mTc injection + LS + SPECT/CT time vs SPIO injection + MRI	Time/duration of 99mTc injection + LS + SPECT/CT and time/duration of SPIO injection + MRI will be compared	During SLNB (surgery)
Secondary	Number of post-injection (skin) reactions, complication and adverse events	Descriptive only	At 10-14 days and at 3 months after the procedure