D4 Choline Breast PET/CT

Prior treatment

• 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

Lab values

• 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

Other

• Pregnant or lactating women
• Participants with severe claustrophobia or who are unable to lie flat or fit into the scanner (≥350 lbs (160 Kg))

• 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