Imaging tumor angiogenesis using 18F-Fluciclatide PET/CT in patients with colorectal and pancreatic cancer
- Conditions
- Pancreatic cancer, colorectal cancer.
- Registration Number
- NL-OMON21459
- Lead Sponsor
- MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Biopsy proven primary colorectal adenocarcinoma or suspected pancreatic ductal adenocarcinoma, as agreed on by multidisciplinary team;
No prior chemo(radio)therapy in rectal cancer patients.
Patient scheduled to undergo surgery;
Patients treated in the LUMC.
Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations
Contraindication for PET (pregnancy, breast-feeding and severe claustrophobia);
Impaired renal function (creatinine clearance < 60 mL/min according to the CockcroftGault equation or ureum < 2x ULN (Upper limit of normal);
Impaired liver function (ALAT, ASAT > 3 ULN or total bilirubin >2x ULN);
Known allergy to pABA (p-aminobenzoate sodium salt);
Presence of any psychological, familial, sociological or geographical conditionpotentially hampering compliance with the study protocol and follow-up schedule;
Inability to tolerate lying supine for the duration of a PET/CT examination (~30min).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess feasibility and sensitivity of imaging tumor angiogenesis in PDAC and colorectal adenocarcinoma, using 18F-Fluciclatide. When successful, the data of this study will allow for a larger trial.
- Secondary Outcome Measures
Name Time Method To define the most optimal PET acquisition time interval after i.v. administration of 18F-Fluciclatide PET/CT;<br>To validate 18F-Fluciclatide as a clinical marker of angiogenesis by immunohistochemistry assessment of angiogenesis in PDAC and colorectal adenocarcinoma resection specimens.