Assess the feasibility of [18F]-DCFPyL PET/CT imaging to detect primary colon, gastric and pancreatic cancer.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quantification of the accumulation of [18F]-DCFPyL (by using SUV and/or RUV) in
the primary tumor on PET/CT imaging.
Secondary outcome
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]-DCFPyL PET/CT-scan, [18F]-FDG-PET/CT, MR imaging, CT imaging,
gastroscopy, colonoscopy).
Sensitivity of DCFPyL is defined as a proportion of: patients with positive
imaging signal/total patient population (with a 95% confidence interval).
Imaging signal will be scored in dichotomous variable (yes/no)
Background summary
Currently, optimal and adequate non-invasive diagnostic modalities to assess
initial nodal staging and local or distant metastatic status in both colon,
gastric and pancreatic cancer patients are lacking. To adequately assess
initial disease stage, further optimization of non-invasive imaging approaches
is crucial. Possibly, better staging can optimize patient stratification
resulting in more effective treatment and avoidance of futile surgery and heavy
perioperative treatment.
PSMA expression on the tumor-associated neovasculature was detected in 85% of
colorectal carcinomas, 66% of gastric carcinomas, and 84% of pancreatic cancer
patients. These PSMA receptors can be selectively targeted by the DCFPyL
peptidomimetic. By labelling DCFPyL with the radioisotope Fluorine-18,
[18F]-DCFPyL, preoperative imaging using positron emission tomography (PET/CT)
is possible. In this feasibility study, we will validate the value of the
preoperative [18F]-DCFPyL PET/CT imaging to identify primary colon, gastric and
pancreatic cancer.
Study objective
Assess the feasibility of [18F]-DCFPyL PET/CT imaging to detect primary colon,
gastric and pancreatic cancer.
Study design
This pilot study is a phase II, multicenter study in primary colon (cohort 1),
gastric (cohort 2) and pancreatic cancer (cohort 3) patients. This study will
assess the feasibility of detecting primary colon, gastric and pancreatic
cancer by preoperative [18F]-DCFPYL PET/CT imaging of the primary tumor. For
this study 10 patients with primary T3-4N0-2M0-1 colon adenocarcinoma, 10
patients with primary gastric adenocarcinoma and 10 patients with suspected
pancreatic ductal adenocarcinoma will be included. All patients will undergo
standard-of-care treatment, with additionally [18F]-DCFPyL PET/CT imaging prior
to surgery. In addition, all patients in cohort 1 and 3 will undergo one
[18F]-FDG PET scan preoperatively. All patients will receive 180 MBq
[18F]-DCFPYL, and 80MBq [18F]-FDG (only cohort 1 and 3) after which a PET/CT
scan will be performed. The sensitivity of [18F]-DCFPyL PET/CT will be
determined and compared to [18F]-FDG PET/CT. Validation will take place by
histopathologic assessment of the resection specimen to determine the presence
(or absence) of viable tumor tissue and immunohistochemically assessment of
PSMA expression in the tumor associated vasculature.
Study burden and risks
The risks of participation for subjects in the trial include risks correlated
to [18F]-DCFPyL, and exposure to radiation. These risks are deemed minimal for
the PET-tracer which already tested safe in humans and used in many clinics all
over the world. Nevertheless, precautionary measures (supervised administration
by qualified staff and availability of medical treatment to treat adverse
reactions) are in place. When unexpected allergic reactions occur, trained
personnel will be present to treat the reaction. There is extensive experience
with the administration of [18F]-DCFPyL and the risk of adverse reactions is
very small (no adverse events observed so far), therefore no extra safety
measures will be taken. After the observational period (which ends after PET/CT
scanning), the intravenous line will be removed and the patient will be
discharged with adequate advice to contact if necessary.
Albinusdreef 3
Leiden 2333RC
NL
Albinusdreef 3
Leiden 2333RC
NL
Listed location countries
Age
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).
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-002462-12-NL |
| CCMO | NL70085.058.19 |