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PET/CT Robustness In Melanoma

PET/CT Robustness In Melanoma - PRIME

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48328
Enrollment
28
Registered
2020-03-26
Start date
2021-12-13
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Melanoma mole cancer

Interventions

None listed

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The main study parameter is the variation in [18F]-FDG PET/CT quantification features between the test and retest scan.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)