Optimalisatie van de behandeling van uitgezaaide darmkanker met cetuximab middels opname metingen van 89Zr gelabeld cetuximab mbv PET.
Completed
- Conditions
- metastatic colorectal cancer,
- Registration Number
- NL-OMON25781
- Lead Sponsor
- VU Univeristy Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
1. Advanced colorectal adenocarcinoma;
2. Subjects must have been treated according to standard care with a fluoropyrimidine (e.g. fluorouracil or capecitabine), irinotecan, and oxaliplatin or had contra-indications to treatment with these drugs;
Exclusion Criteria
1. Previous exposure to an anti-EGFR therapy;
2. Significant skin condition interfering with treatment;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate uptake of 89Zr-cetuximab in non-hepatic tumor lesions using immuno-PET when administered during the loading dose of cetuximab. <br><br /><br /><br>Part two - Primary objective:<br /><br>To investigate whether there is an association between uptake of cetuximab in non-hepatic tumor lesions and response according to RECIST 1.1 criteria.
- Secondary Outcome Measures
Name Time Method 1. To investigate whether there is an association between levels of uptake of 89Zr-cetuximab in the liver compared to levels of uptake in non-hepatic tumor lesions;<br /><br>2. To explore whether the response observed on [18F]-FDG-PET can serve as an early response marker for future response to targeted therapy according to RECIST 1.1;<br /><br>3. To explore whether there is an association between 89Zr-cetuximab uptake in non-hepatic tumor lesions, grade of skin toxicity and response according to RECIST 1.1.