Opname en biodistributie van 89Zirconium gelabeld ipilimumab in melanoompatiënten die behandeld worden met ipilimumab
- Conditions
- Immuno_PET Melanoma (melanoom)IpilimumabImmunotherapy (imuumtherapie)89Zirconium
- Registration Number
- NL-OMON27886
- Lead Sponsor
- VU University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 29
Inclusion Criteria
Advanced/metastatic melanoma.
- Scheduled for treatment with ipilimumab.
Exclusion Criteria
- Previous exposure to ipilimumab.
- Pregnant or breast-feeding subjects.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The detection of 89Zr-ipilimumab in tumor lesions (after first injection of ipilimumab) and in week 4 (after second injection of ipilimumab). Tumor lesions will be defined using a diagnostic CT-scan or MRI. The short axis diameter of a measurable tumor lesion is ¡Ý1 cm. The five largest lesions will be used for evaluation:<br /><br>- Visual: present/absent; present being as focally enhanced uptake on the immuno-PET scan with optimal contrast (72-144 hours post injection).<br /><br>- Quantitative: measured in mean and peak Standardized Uptake Value (SUVmean and SUVpeak) of the tumor lesions with the highest antibody uptake, using automatic delineated tumor volumes of interest (VOI's). Targeting is defined as SUVtumor/SUVblood >1.
- Secondary Outcome Measures
Name Time Method