Imaging tumor angiogenesis using [18F]-DCFPyL PET/CT in patients with colon, gastric and pancreatic cancer.

Phase 2

Recruiting

Conditions: bowel cancer
pancreatic cancer
stomach cancer
10017990
10017991

Registration Number: NL-OMON49020

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Patients aged 18 years or older.
Diagnosis of primary T3-4N0-2M0-1 colorectal adenocarcinoma (cohort 1) or
primary gastric carcinoma (cohort 2), or primary pancreatic cancer (cohort 3).
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.

Exclusion Criteria

Any condition that in the opinion of the investigator could potentially
jeopardize the health status of the patient.
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-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).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Quantification of the accumulation of [18F]-DCFPyL (by using SUV and/or RUV) in<br /><br>the primary tumor on PET/CT imaging.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Assess agreement between PET/CT-imaging signal in the cancer and<br /><br>histopathologic evidence of cancer and PSMA expression by the cancer cells or<br /><br>endothelial cells of newly formed capillaries.<br /><br>Assess the agreement between different preoperative imaging modalities (e.g.<br /><br>[18F]-DCFPyL PET/CT-scan, [18F]-FDG-PET/CT, MR imaging, CT imaging,<br /><br>gastroscopy, colonoscopy).<br /><br><br /><br>Sensitivity of DCFPyL is defined as a proportion of: patients with positive<br /><br>imaging signal/total patient population (with a 95% confidence interval).<br /><br>Imaging signal will be scored in dichotomous variable (yes/no)</p><br>