Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ER Positive Breast Cancer | — | UNRESOLVED | — |
| HER2-negative Breast Cancer | — | UNRESOLVED | — |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imaging scan | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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
- timeFrame
- Through scan completion 4-6 weeks
- description
- PET/CT
Secondary outcomes (2)
- measure
- 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)
- timeFrame
- Through study completion, an average 2.5 years
- description
- PET/CT
- measure
- Correlation of [18F]D4-FCH uptake with tumour size or FDG-PET or appropriate standard clinical imaging
- timeFrame
- Through study completion, an average 2.5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients with a histological diagnosis of locally advanced or metastatic estrogen-receptor positive, HER2 negative breast cancer 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: 1. Pregnant or lactating women 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
References
Publications (0)
Data not yet available