No registrations found.
ID
Source
Brief title
Health condition
Pancreatic cancer, colorectal cancer.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assess feasibility and sensitivity of imaging tumor angiogenesis in PDAC and colorectal adenocarcinoma, using 18F-Fluciclatide. When successful, the data of this study will allow for a larger trial.
Secondary outcome
To define the most optimal PET acquisition time interval after i.v. administration of 18F-Fluciclatide PET/CT;
To validate 18F-Fluciclatide as a clinical marker of angiogenesis by immunohistochemistry assessment of angiogenesis in PDAC and colorectal adenocarcinoma resection specimens.
Background summary
18F-Fluciclatide PET imaging in colorectal and pancreatic cancer detection.
Study objective
18F-Fluciclatide PET imaging can detect colorectal and pancreatic lesions.
Study design
.
Intervention
18F-Fluciclatide PET scan
Inclusion criteria
Biopsy proven primary colorectal adenocarcinoma or suspected pancreatic ductal adenocarcinoma, as agreed on by multidisciplinary team;
No prior chemo(radio)therapy in rectal cancer patients.
Patient scheduled to undergo surgery;
Patients treated in the LUMC.
Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations
Exclusion criteria
Contraindication for PET (pregnancy, breast-feeding and severe claustrophobia);
Impaired renal function (creatinine clearance < 60 mL/min according to the CockcroftGault equation or ureum < 2x ULN (Upper limit of normal);
Impaired liver function (ALAT, ASAT > 3 ULN or total bilirubin >2x ULN);
Known allergy to pABA (p-aminobenzoate sodium salt);
Presence of any psychological, familial, sociological or geographical conditionpotentially hampering compliance with the study protocol and follow-up schedule;
Inability to tolerate lying supine for the duration of a PET/CT examination (~30min).
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL7605 |
| Other | METC LUMC : P18.210 |