Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
6 participants
OBSERVATIONAL
2022-02-24
2023-11-03
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Imaging scan
PET/CT scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Written informed consent prior to admission in the study.
3. Target lesion diameter of ≥15mm that has not been previously irradiated and is located outside the liver
4. Female patients aged ≥ 18 years of age
5. For all patients: histologically confirmed locally advanced/ metastatic breast cancer with a previous biopsy confirming hormone receptor and HER2 status
6. ECOG performance status 0-2
7. 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
8. Life expectancy \> 3months
9. Adequate organ function as judged by investigator to include:
* Hb≥ 10g/L
* Creatinine clearance ≥45ml/min
10. 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 Criteria
2. 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
3. Participants with severe claustrophobia or who are unable to lie flat or fit into the scanner (≥350 lbs (160 Kg))
4. Prior use within 14 days of enrolment or concurrent therapy with any other investigational agent
5. Patients classified as radiation workers
6. Patient has previously received treatment with CDK 4/6 inhibitors
18 Years
FEMALE
No
Sponsors
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Medical Research Council
OTHER_GOV
ECMC
UNKNOWN
Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Laura Kenny
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Imperial College Healthcare NHS Trust/ Imperial College London
London, , United Kingdom
Countries
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Other Identifiers
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249165
Identifier Type: OTHER
Identifier Source: secondary_id
18HH4880
Identifier Type: -
Identifier Source: org_study_id
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