Trials / Completed
CompletedNCT04276272
D4 Choline Breast PET/CT
Investigation of Changes in Tumour Choline Metabolism in Estrogen-receptor Positive / HER2 Negative Breast Cancer Patients Treated With CDK4/6 Inhibitors and Endocrine Therapy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 6 (actual)
- Sponsor
- Imperial College London · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- —
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Imaging scan | PET/CT scan |
Timeline
- Start date
- 2022-02-24
- Primary completion
- 2023-11-03
- Completion
- 2023-11-03
- First posted
- 2020-02-19
- Last updated
- 2024-08-26
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04276272. Inclusion in this directory is not an endorsement.