D4 Choline Breast
Research type
Research Study
Full title
Investigation of changes in tumour choline metabolism in estrogen-receptor positive / HER2 negative breast cancer patients treated with CDK4/6 inhibitors and endocrine therapy
IRAS ID
249165
Contact name
Laura Kenny
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
The aim of this study is to evaluate the effect of CDK4/6 inhibitor treatment on the tumour choline metabolism as determined by [18F]D4-FCH PET/CT in breast cancer and to determine the suitability of [18F]D4-FCH-PET/CT as a non-invasive, early imaging biomarker for therapy response following CDK4/6 inhibitor treatment. This study will allow us to quantify changes to choline metabolism within tumours using [18F]D4-FCH-based PET/CT and to evaluate early therapy response to standard of care CDK4/6 inhibitor combination therapy. To this end, patients with histologically confirmed hormone-receptor positive, HER2-negative, locally advanced or metastatic breast cancer will undergo 2 PET/CT imaging scans in total as part of the study using [18F]D4-FCH radiotracer (at baseline & 4-6 weeks after starting treatment). A blood sample (≤ 30mls) will be taken before each PET/CT scan to measure circulating tumour DNA. 1-2 tissue biopsies may be taken for analysis of exploratory biomarkers and genes associated with the KRAS pathway. Study target is 16 evaluable data subjects.
PET/CT imaging will be conducted over approximtaley 90 minutes per scan using [18F]D4-FCH, which is a radiotracer which allows for the determination of differences in choline metabolism in tumour (high level of choline metabolism) compared to non-tumour tissue (lower choline metabolism). Radiotracer uptake will be measured prior to treatment (scan 1) and then again at 4-6 weeks after commencing CDK4/6 inhibitor/endocrine therapy (scan 2). We can then measure and assess whether choline metabolism in the body changes between scan 1 and scan 2.
The study will not involve any change to the patient's normal clinical pathway.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
19/EE/0349
Date of REC Opinion
6 Jan 2020
REC opinion
Further Information Favourable Opinion