FRONTIER: Fluciclovine (18F) imaging of breast cancer
Research type
Research Study
Full title
FRONTIER: An open-labelled study to characterise Fluciclovine (18F) uptake measured by positRon emissiON Tomography In breast cancER
IRAS ID
207769
Contact name
Adrian Harris
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
2 years, 1 months, 30 days
Research summary
With an increasing number of new breast cancer therapies, there is ongoing need for strong predictors and measures of treatment response, to inform personalised treatment, while minimising side effects and cost of potentially unsuccessful therapies. Better predictors of benefit will improve cost-effectiveness.
PET (positron emission tomography) imaging provides a picture of the metabolic processes that occur within a tumour (metabolism), for example its use of glucose. The commonest PET agent, fluorodeoxyglucose, is glucose modified so it can be detected on imaging.
Amino acids are the building blocks of proteins. The purpose of this study is to find out whether a new amino acid PET agent, fluciclovine (18F), shows differences in uptake between breast cancer subtypes. We want to find out how this is related to amino acids in the tumour, and the metabolism and growth pathways that transport and use them. If there is a strong correlation of uptake with tumour biology, the uptake may help classify patients into those with tumours most likely to respond, and also measure very early response, potentially after 1-2 weeks. This will depend on the outcome of our study and whether it does allow us to detect these pathways non-invasively in future.
We aim to recruit 40 women with invasive breast cancer, and 5 early non-invasive breast cancer, who are going to receive surgical treatment in the Oxford University Hospitals NHS Foundation Trust. Each participant will be on study for approximately 1 month, and will receive a research scan (fluciclovine (18F) PET/CT) prior to surgery. Research blood samples will be collected on scan day. During surgery, under anaesthesia, research biopsies will be collected from the tumour. Analyses of the research samples for growth rate, amino acid transporter, type of breast cancer and metabolism enzymes will then be compared to tumour uptake of fluciclovine (18F).
REC name
South Central - Oxford A Research Ethics Committee
REC reference
16/SC/0645
Date of REC Opinion
14 Dec 2016
REC opinion
Favourable Opinion