Imaging tumor angiogenesis using [18F]-DCFPyL PET/CT in patients with colon, gastric and pancreatic cancer.
- Conditions
- Colon, gastric and pancreatic cancer.
- Registration Number
- NL-OMON27578
- Lead Sponsor
- MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
• Patients aged 18 years or older.
• Diagnosis of primary T3-4N0-2M0-1 colorectal adenocarcinoma (cohort 1), primary T3-4N0-
2M0 gastric carcinoma (cohort 2), or suspected pancreatic ductal adenocarcinoma (cohort 3)
and eligible for surgery.
• Before patient registration, written informed consent must be given according to ICH/GCP,
and national/local regulations.
• Women who are pregnant and/or or lactating.
• Medical or psychiatric conditions that compromise the patient’s ability to give informed
consent. Presence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule.
• Prior radiotherapy to the abdomen (cohort 1, 2 and 3) and/or thorax (cohort 2 and 3).
• Unacceptable known (clinically significant) cardiovascular or pulmonary disease, renal or liver
dysfunction, which could hamper participation in this study or jeopardize the patients’ health.
• Known hypersensitivity to drugs comparative to DCFPYL, or any of their excipients or to any
component of [18F]-DCFPYL.
• Inability to undergo PET/CT scanning (e.g. claustrophobia, weight limits or inability to tolerate
lying for the duration of a PET/CT scan (~30 min).
• Inability to undergo routine MRI or CT scans as part of the diagnostic work up.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine if primary colon, gastric and pancreatic cancer can be detected by [18F]-DCFPYL PET/CT<br>imaging.
- Secondary Outcome Measures
Name Time Method - Assess agreement between the [18F]-DCFPYL PET/CT-imaging signal in the cancer and<br>histopathologic evidence of cancer and PSMA expression on the resection specimen.<br>- Assess the agreement of [18F]-DCFPYL PET/CT and other preoperative imaging modalities<br>([18F]-FDG-PET/CT, MR imaging, CT imaging, gastroscopy, colonoscopy).