Status:
COMPLETED
D4 Choline Breast PET/CT
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Medical Research Council
ECMC
Conditions:
HER2-negative Breast Cancer
ER Positive Breast Cancer
Eligibility:
FEMALE
18+ years
Brief 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 deter...
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 ...
Eligibility Criteria
Inclusion
- Female patients with a histological diagnosis of locally advanced or metastatic estrogen-receptor positive, HER2 negative breast cancer
- Written informed consent prior to admission in the study.
- Target lesion diameter of ≥15mm that has not been previously irradiated and is located outside the liver
- Female patients aged ≥ 18 years of age
- For all patients: histologically confirmed locally advanced/ metastatic breast cancer with a previous biopsy confirming hormone receptor and HER2 status
- ECOG performance status 0-2
- Negative urine pregnancy test (within 2 hours prior to injection of imaging agent) in women of child bearing age and willingness to use contraception (barrier, abstinence, non-hormonal) for 3 weeks after injection of \[18F\]D4-FCH
- Life expectancy \> 3months
- Adequate organ function as judged by investigator to include:
- Hb≥ 10g/L
- Creatinine clearance ≥45ml/min
- Patients must have been appropriately staged (which may include contrast enhanced CT/ FDG-PET/ MRI) within 42 days of study entry and additional imaging according to local standard of care
Exclusion
- Pregnant or lactating women
- Evidence of significant medical condition or laboratory finding which, in the opinion of the Investigator, makes it undesirable for the patient to participate in the trial
- Participants with severe claustrophobia or who are unable to lie flat or fit into the scanner (≥350 lbs (160 Kg))
- Prior use within 14 days of enrolment or concurrent therapy with any other investigational agent
- Patients classified as radiation workers
- Patient has previously received treatment with CDK 4/6 inhibitors
Key Trial Info
Start Date :
February 24 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 3 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04276272
Start Date
February 24 2022
End Date
November 3 2023
Last Update
August 26 2024
Active Locations (1)
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1
Imperial College Healthcare NHS Trust/ Imperial College London
London, United Kingdom, W12 0NN