Evaluating the feasibility of 18F-Fluciclatide PET/CT imaging of colorectal and pancreatic tumors.
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
Sensitivity/specificity of 18F-Fluciclatide.
Secondary outcome
Optimal imaging window of this tracer
Feasibility of responsemonitoring with this tracer
Background summary
In both colorectal and pancreas carcinoma treatment, neoadjuvant treatment
protocol are used more frequently. As a consequence of this therapy, tumor
shrinkage is seen and even in some cases resection of the primary tumor is not
necessary.
However, using the current imaging modalities available (CT, MRI and PET/CT),
tumor response monitoring to neoadjuvant therapy is challenging.
In this study, we propose tumor response monitoring using 18F-Fluciclatide.
This new PET tracer targets integrins which are expressed on neoangiogensis
associated with both colorectal and pancreatic tumors.
Study objective
Evaluating the feasibility of 18F-Fluciclatide PET/CT imaging of colorectal and
pancreatic tumors.
Study design
Colorectal and pancreatic carcinoma patients will be asked to undergo one or
two 18F-Fluciclatide PET/CT scan(s). This way, after resection, imaging
findings can be correlated to integrin expression on the tumor resection
specimen and the feasibility of response monitoring will be assessed.
Study burden and risks
Moderate. Since no adverse events have been observed from the use of this
tracer before, we expect no allergic reactions.
Albinusdreef 3
Leiden 2333RC
NL
Albinusdreef 3
Leiden 2333RC
NL
Listed location countries
Age
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.
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
Cockcroft-Gault 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 condition
potentially 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
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | EUCTR2018-003522-86-NL |
| CCMO | NL67454.058.18 |