PET/CT Robustness In Melanoma

Recruiting

• Conditions: Melanoma; mole cancer; 10040900

• Registration Number: NL-OMON48328
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

1. *18 years old
2. Histopathologically confirmed melanoma
3. Clinical stage IIIB/C/D, IV melanoma
4. Scheduled for a routine baseline [18F]-FDG PET/CT scan
5. Minimal one lesion with longest diameter * 20 mm
6. WHO performance status * 2
7. Ability to undergo the scan in supine position
8. Capacity to give informed consent

Exclusion Criteria

1. Pregnant
2. Breast feeding
3. Claustrophobia
4. Confirmed diabetes mellitus I or II
5. Body weight >100 kg
6. Metal implants/prostheses, evaluated by study team
7. No systemic therapy (chemotherapy, immunotherapy, targeted therapy) 3
months prior to scan

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the variation in [18F]-FDG PET/CT quantification<br /><br>features between the test and retest scan.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Our secondary endpoints are the variation between post processing settings on<br /><br>the quantitative [18F]-FDG PET/CT features within scans. As quality control<br /><br>quantitative [18F]-FDG PET/CT features will also be measured on normal organ<br /><br>tissue. The amount of tumour lesions and their size will be measured. </p><br>