Colon and gastric cancer patients
Conditions
Interventions
Product Name: [18F]PSMA-1007
Product Code: [18F]PSMA-1007
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: F-18-PSMA-1007
Other descriptive name: F-18-PSMA-1007
Concentration
Sponsors
Leiden Universitair Medisch Centrum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients aged 18 years or older. • Diagnosis of primary T3-4N0-2M0-1 colorectal adenocarcinoma (cohort 1) or primary T3-4N0-2M0 gastric carcinoma (cohort 2) and eligible for surgery. • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. • 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Any condition that in the opinion of the investigator could potentially jeopardize the health status of the patient. • Women who are pregnant and/or or lactating. • Diabetes Mellitus • 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 and 2) and/or thorax (cohort 2). • Unacceptable known (clinically significant) cardiovascular or pulmonary disease, renal or liver dysfunction. • Known hypersensitivity to drugs comparative to PSMA-1007, or any of their excipients or to any component of [18F]-PSMA-1007. • 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 |
|---|---|
| Timepoint(s) of evaluation of this end point: At early stopping rule and end of study;Main Objective: Assess the feasibility of [18F]-PSMA-1007 PET/CT imaging to detect primary colon and gastric cancer.;Primary end point(s): Quantification of the accumulation of [18F]-PSMA-1007 (by using TBR, SUV and/or RUV) in the primary tumor on PET/CT. Tumor imaging is feasible (positive) at a TBR = 2. ;Secondary Objective: Assess association between the in vivo [18F]-PSMA-1007 PET/CT-imaging uptake in the tumor and histopathologic evidence of tumor tissue and PSMA expression determined on the resection specimen. Assess the agreement between different preoperative imaging modalities (e.g. [18F]-PSMA-1007 PET/CT-scan, [18F]-FDG-PET/CT, MR imaging, CT imaging, gastroscopy, colonoscopy). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Assess agreement between PET/CT-imaging signal in the cancer and histopathologic evidence of cancer and PSMA expression by the cancer cells or endothelial cells of newly formed capillaries. Assess the agreement between different preoperative imaging modalities (e.g. [18F]-PSMA-1007 PET/CT-scan, [18F]-FDG-PET/CT, MR imaging, CT imaging, gastroscopy, colonoscopy). ;Timepoint(s) of evaluation of this end point: At early stopping rule and end of study | — |
Countries
Netherlands
Contacts
Public ContactPhD student
Leiden Universitair Medisch Centrum
Outcome results
None listed