IMPACT
Research type
Research Study
Full title
IMaging pilot study of the αvβ6 integrin radiotracer [18F]A20FMDV2 in PAtients with solid Cancer Types
IRAS ID
179160
Contact name
Peter Schmid
Contact email
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Research Summary:
Integrin alpha v beta six (αvβ6) is present in increased amounts on a number of cancer cells and is known to play a prominent role in the development and spread of cancer. FBA-A20FMDV2 is a substance that binds or sticks to integrin αvβ6. It may therefore be possible to identify and measure the amount of integrin αvβ6 in tumours by attaching a small amount of radioactivity to FBA-A20FMDV2 and carrying out a scan called a PET scan. FBA-A20FMDV2 attached to radioactivity is known as [18F]FBA-A20FMDV2 or a radiotracer, as a very small amount of tracer doses are given to man. Such scans have been carried out in healthy volunteers and in patients with a lung condition called idiopathic pulmonary fibrosis (IPF) in order to look at the safety of the radiotracer and how it is taken up in the body. However, they have not been carried out in cancer patients. IMPACT will help us find out how [18F]FBA-A20FMDV2 is taken up in tumours and this information will be used to develop the ideal imaging method for patients with cancer.12 participants with pancreas, head and neck and breast cancers, whose tumours measure ≥ 1cm in diameter will be on study for 3 weeks and they will undergo one dynamic [18F]-A20FMDV2 PET Scan. Participants will be called within 3 days following their scan to check how they are feeling and will attend a hospital visit 2-3 weeks after the day of the PET Scan to give some blood samples. All patients will be recruited from the oncology clinics at Barts Health NHS Trust and will undergo scans at Imanova Centre for Imaging Sciences. αvβ6 levels will also be measured on tumour samples collected from patients as part of their normal clinical care.
Lay summary of study results:
Integrin alpha v beta six (αvβ6) is present in increased amounts on several cancer cells and is known to play a prominent role in the development and spread of cancer. FBAA20FMDV2 is a substance that binds or sticks to integrin αvβ6. It may therefore be possible to identify and measure the amount of integrin αvβ6 in tumours by attaching a small amount of radioactivity to FBAA20FMDV2 and carrying out a scan called a PET scan. FBAA20FMDV2 attached to radioactivity is known as [18F]FBAA20FMDV2.
The primary objective of the study was to evaluate the feasibility of [18F]-FBA-A20FMDV2-PET imaging in patients with solid tumours. The secondary objective was to optimise the PET scan time, duration and the imaging protocol for future studies and the exploratory objective was to explore the relationship between [18F]-FBA-A20FMDV2 uptake in tumours and the tumour αvβ6 expression.
In the study, PET scan of 10 patients with solid tumours were successfully acquired after administration of [18F]-FBA-A20FMDV2. Tumours and/or metastases were identified in 7 out of 10 analysed subjects. The characteristic time-activity curves for individual normal tissues were generated. Standardised uptake value (SUV) was generated between 30-50 min, as it was the time interval presenting the most difference between normal and tumour tissue. SUVR were calculated using SUV in aorta as reference. Highest uptake was in kidneys followed by stomach, spleen, liver, and vertebral body. For pancreatic tumours, uptake (SUV and SUVR) was lesser than the corresponding normal tissue, while for liver metastases, uptake (SUV and SUVR) showed a heterogeneous pattern. Exploratory objective is not being reported here.REC name
London - West London & GTAC Research Ethics Committee
REC reference
15/LO/1266
Date of REC Opinion
24 Sep 2015
REC opinion
Further Information Favourable Opinion