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

NCT05145829 | Unknown DMC

• 1 other identifier: METCZ20210156
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma

Keywords

Magnetic tracer; Sentinel lymph node; Melanoma; MRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The diagnostic accuracy of SPIO/magnetometer and PB, 99mTc and Gamma probe

  During SLNB (surgery)

• Comparison between 99mTc injection + LS + SPECT/CT time vs SPIO injection + MRI

  During SLNB (surgery)

• Number of post-injection (skin) reactions, complication and adverse events

  At 10-14 days and at 3 months after the procedure

Study Arms (1)

Melanoma patients

EXPERIMENTAL

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

Diagnostic Test: Diagnostic Test: Sentinel node mapping using MRI

Interventions

Diagnostic Test: Sentinel node mapping using MRI DIAGNOSTIC_TEST

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

Melanoma patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland Medical Center

Sittard, Limburg, 6162BG, Netherlands

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

James van Bastelaar, MD, PhD

CONTACT

0884597777; j.vanbastelaar@zuyderland.nl

Loeki Aldenhoven, MSc

CONTACT

0884597777; l.aldenhoven@zuyderland.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of Surgery (MD, PhD)

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: December 6, 2021
• Study Start: September 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)