Exploring an alternative pre-operative sentinel lymph node mapping method using a Magnetic tracer and MRI for melanoma patients

Recruiting

Conditions: Melanoma
skin cancer
10040900

Registration Number: NL-OMON51995

Lead Sponsor: Heelkunde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 140

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The diagnostic accuracy of SPIO/MRI and LS+SPECT/CT and 99mTc to identify SLN<br /><br>will be expressed as sensitivity and specificity, and positive and negative<br /><br>predictive values, including their 95% exact binomial confidence intervals. MRI<br /><br>image analyses will be performed by two independent professionals. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The diagnostic accuracy of SPIO/magnetometer and 99mTc and Gamma probe will be<br /><br>expressed as sensitivity and specificity, and positive and negative predictive<br /><br>values, including their 95% exact binomial confidence intervals.<br /><br>Comparison between 99mTc injection + LS + SPECT/CT time vs SPIO injection + MRI<br /><br>Number of days between preoperative MRI and SLNB.<br /><br>Moreover, the MRI workflow protocol will be validated and potentially<br /><br>optimized. </p><br>