D4 Choline Breast PET/CT

Status Recruiting

Clinical Trial 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/ 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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04276272
Study type	Observational
Source	Imperial College London
Contact	Bhavesh Pratap
Phone	0442033133720
Email	b.pratap@imperial.ac.uk
Status	Recruiting
Phase
Start date	February 24, 2022
Completion date	November 3, 2024

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