Clinical Trial · NCT04285996

IMaging Pilot Study of the αvβ6 Integrin Radiotracer [18F]-A20FMDV2 in PAtients With Solid Cancer Types

Overview

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 in cancer cells can be measured by carrying out PET scans, we might be able to identify and potentially treat tumours. FBA-A20FMDV2 is a substance that binds or sticks to integrin αvβ6. It may therefore be possible to find and measure the amount of integrin αvβ6 in tumours. To do this a small amount of radioactivity will be attached to FBA-A20FMDV2 and carry out a scan called a Positron Emission Tomography (PET) scan. FBA-A20FMDV2 attached to radioactivity is known as \[18F\]FBA-A20FMDV2 or a radiotracer, as a very small amount of tracer dose is given to humans. So far such scans have been carried out in healthy volunteers and in patients with a lung condition called idiopathic pulmonary fibrosis (IPF). This was to assess the safety of the radiotracer and how it is taken up in the body. However, such scans have not been performed in cancer patients. This study will help specifically investigate αvβ6 in patients with cancer and find out how \[18F\]FBA-A20FMDV2 is taken up in tumours. With this information, the ideal imaging method for patients with cancer can be developed.

Sponsor

Unknown Organization

Phase

N/A

Contacts

John Marshall (PRINCIPAL_INVESTIGATOR)

Peter Schmid (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04285996

Drug / Compound

FBA-A20FMDV2

Isotope(s):

Target(s):

αvβ6

Ligand Class: Peptides

Linker: 4-fluorobenzoyl

Eligibility

Inclusion

ECOG performance status of 0-2
Availability of a formalin fixed, paraffin embedded (FFPE) tumour sample for central assessment.2
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
Negative urine pregnancy test for female patients of childbearing potential prior to study entry1.
Clinical diagnosis of a solid tumour measuring ≥1cm in the longest diameter as assessed by clinical imaging or by physical clinical evaluation.
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.

Exclusion

Subject feels unable to lie flat and still on their back for a period of up to 95 minutes in the PET/CT scanner.
Breast feeding female patients.
Previous long-term (≥ 3 months) residence in a country where FMDV2 is endemic (such as certain areas of Africa, Asia and South America).
Previous or current exposure to animals that may harbour the foot and mouth disease virus FMDV2