Status:
COMPLETED
IMaging Pilot Study of the αvβ6 Integrin Radiotracer [18F]-A20FMDV2 in PAtients With Solid Cancer Types
Lead Sponsor:
Queen Mary University of London
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A substance called integrin alpha v beta six (αvβ6) is found to be increased in some cancer cells and can play an important role in the development and spread of cancer. If the levels of integrin αvβ6...
Detailed Description
The epithelial specific integrin αvβ6 is not expressed by resting epithelia (1) but is up regulated in several cancers. It has been estimated that approximately 250,000 or 15% of new cancers (excludin...
Eligibility Criteria
Inclusion
- Able to give written informed consent prior to admission to this study.
- Female or male aged ≥18 years
- ECOG performance status of 0-2
- Clinical diagnosis of a solid tumour measuring ≥1cm in the longest diameter as assessed by clinical imaging or by physical clinical evaluation.
- Female patients of childbearing potential or male patients with female partners of child-bearing potential must agree to use adequate contraception as described in the protocol from the day of the scan and until 4 weeks after the scan
- Haematologic indices (FBC, WBC, ANC, platelets count and haemoglobin) and biochemical indices (sodium, potassium, chloride, urea, creatinine, total protein, albumin, total bilirubin, ALP and AST) within local institutional limits.
- Negative urine pregnancy test for female patients of childbearing potential prior to study entry1.
- Availability of a formalin fixed, paraffin embedded (FFPE) tumour sample for central assessment.2
Exclusion
- Breast feeding female patients.
- Previous or current exposure to animals that may harbour the foot and mouth disease virus FMDV2
- Previous long-term (≥ 3 months) residence in a country where FMDV2 is endemic (such as certain areas of Africa, Asia and South America).
- Subject feels unable to lie flat and still on their back for a period of up to 95 minutes in the PET/CT scanner.
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of the tracer, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
Key Trial Info
Start Date :
March 17 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2022
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04285996
Start Date
March 17 2016
End Date
July 15 2022
Last Update
July 8 2024
Active Locations (1)
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1
Barts Health NHS Trust
London, United Kingdom