Colon, gastric and pancreatic cancer.
Conditions
Interventions
[18F]DCFPyL PET/CT, [18F]FDG PET/CT scan
Sponsors
LUMC
Eligibility
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine if primary colon, gastric and pancreatic cancer can be detected by [18F]-DCFPYL PET/CT imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Assess agreement between the [18F]-DCFPYL PET/CT-imaging signal in the cancer and histopathologic evidence of cancer and PSMA expression on the resection specimen. - Assess the agreement of [18F]-DCFPYL PET/CT and other preoperative imaging modalities ([18F]-FDG-PET/CT, MR imaging, CT imaging, gastroscopy, colonoscopy). | — |
Contacts
Public ContactFloris Vuijk
Leiden University Medical Center
Outcome results
None listed