Exploring an alternative pre-operative sentinel lymph node 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 - SCARLETT Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51995

Enrollment

140

Registered

2021-06-20

Start date

2023-02-03

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma skin cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion 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 = 0.8mm with or without ulceration or <0.8mm with ulceration (pT1b - pT4b, AJCC 8th edition)); Indication for wide local excision (margin 1 or 2 cm) and SLN procedure; Patients should be willing and able to provide informed consent.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
The diagnostic accuracy of SPIO/magnetometer and 99mTc and Gamma probe will be expressed as sensitivity and specificity, and positive and negative predictive values, including their 95% exact binomial confidence intervals. Comparision between the pathological outcomes of harvested SLNs, stratified by their pre-operative identification method (SPIO/MRI and/or LS+SPECT/CT using 99mTc), expressed as sensitivity and specificity, and positive and negative predictive values, including their 95% exact binomial confidence intervals. Comparison between 99mTc injection + LS + SPECT/CT time vs SPIO injection + MRI Number of days between preoperative MRI and SLNB.  Moreover, the MRI workflow protocol will be validated and potentially optimized.	—

Measure

Time frame

The diagnostic accuracy of SPIO/magnetometer and 99mTc and Gamma probe will be expressed as sensitivity and specificity, and positive and negative predictive values, including their 95% exact binomial confidence intervals. Comparision between the pathological outcomes of harvested SLNs, stratified by their pre-operative identification method (SPIO/MRI and/or LS+SPECT/CT using 99mTc), expressed as sensitivity and specificity, and positive and negative predictive values, including their 95% exact binomial confidence intervals. Comparison between 99mTc injection + LS + SPECT/CT time vs SPIO injection + MRI Number of days between preoperative MRI and SLNB.  Moreover, the MRI workflow protocol will be validated and potentially optimized.

—

Countries

Netherlands

Contacts

Public ContactJ Van Bastelaar

Zuyderland

j.vanbastelaar@zuyderland.nl0641227350

Outcome results