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/ computed tomography(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.
A target of 16 evaluable participants will be recruited to this study. Participants will have\[18F\]D4-FCH PET/CT imaging on each of 2 visits Scan 1: Baseline scan to be conducted prior to initiating standard of care CDK4/6 inhibitor-based therapy drug therapy. Scan2: Early post-treatment scan to be conducted at 4-6 weeks after initiating therapy. Each participant will provide written consent to take part in the study before they undergo screening assessments to confirm eligibility. On the day of imaging the participants will have a blood sample taken for circulating tumour DNA prior to the scan. A single dose of \[18F\]D4-FCH IV will be administered to the participant followed by dynamic/ whole body imaging. Optional tumour biopsies at baseline and after 4-6 weeks of CDK4/6 inhibitor treatment will be obtained, or if there is a suitable archival pre-treatment biopsy that has been taken within 18 months, this can be retrieved for baseline analysis. Clinical data for progression/ survival followed up for up to 24 months.
Study Type
OBSERVATIONAL
Enrollment
6
PET/CT scan
Imperial College Healthcare NHS Trust/ Imperial College London
London, United Kingdom
The change in tumour uptake of [18F]D4-FCH (standardized uptake at 60 min, fractional retention) after approximately 4-6 weeks of CDK4/6 inhibitor-based therapy in patients with locally advanced or metastatic breast cancer
PET/CT
Time frame: Through scan completion 4-6 weeks
Semi-quantitative assessment of the effect of CDK4/6 inhibitor-based therapy on [18F]D4-FCH tumour and normal tissue dynamics. Uptake of [18F]D4-FCH in normal tissues, and tumour target and non-target lesions combined (dynamic/whole body scans)
PET/CT
Time frame: Through study completion, an average 2.5 years
Correlation of [18F]D4-FCH uptake with tumour size or FDG-PET or appropriate standard clinical imaging
PET/CT
Time frame: Through study completion, an average 2.5 years
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