Patients with clinically suspected (borderline) resectable pancreatic ductal adenocarcinoma with an indication for standard surgical treatment with adjuvant chemotherapy will be included
Conditions
Interventions
Trade Name: [18F]-DCFPyL
Product Name: [18F]-DCFPyL
Product Code: [18F]-DCFPyL
Pharmaceutical Form: Concentrate and solvent for solution for injection
Sponsors
Amsterdam University Medical Center - location VUmc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged 18 years or older - Diagnosis of suspected pancreatic ductal adenocarcinoma and eligible for surgery - Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: - Patients with metastatic PDAC on conventional imaging will be excluded, as current guidelines exclude them from surgery because of no survival benefit. - 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 and/or thorax. - Known hypersensitivity to drugs comparative to 18F-PSMA, or any of their excipients or to any component of 18F-PSMA. - 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 |
|---|---|
| Main Objective: Primary objective: To determine if PDAC can be detected by 18F-PSMA PET-CT imaging. ;Secondary Objective: Secondary objectives: - To assess the agreement between the 18F-PSMA PET-CT imaging signal in PDAC and histopathologic evidence of cancer and PSMA expression on the resection specimen. - To assess the lower limit of PSMA expression on tissue samples still resulting in detectable trace uptake (18F-PSMA “positivity”) on the PET scan (“quantitative” evaluation). This in order to select eligible patients for PSMA-based therapy in the future . ;Primary end point(s): -Assessment of 18F-PSMA PET-CT for detection of pancreatic adenocarcinoma in patients with clinically suspected or histological -proven resectable PDAC, prior to surgery (“qualitative” visual evaluation). ;Timepoint(s) of evaluation of this end point: The PET-CT is performed prior to surgery. After resection of the pancreas, the tissue can be evaluated by histopathologic examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The correlation between localisation 18F-PSMA uptake on PET-CT and PSMA expression in tissue using immunohistochemistry, and - The identification of the lower limit of PSMA expression on tissue samples still resulting in detectable tumours (18F-PSMA “positivity”) on the PET scan (“quantitative” evaluation). This in order to select eligible patients for PSMA-based therapy in the future.;Timepoint(s) of evaluation of this end point: The PET-CT is performed prior to surgery. After resection of the pancreas, the tissue can be evaluated by histopathologic examination. | — |
Countries
Netherlands
Contacts
Public ContactCoordinating investigator
Amsterdam University Medical Center - location VUmc
Outcome results
None listed