Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • ER Positive Breast Cancer
  • HER2 Negative Breast Cancer
  • Metastatic Breast Cancer
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

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 c...

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.

Tracking Information

NCT #
NCT04276272
Collaborators
  • Medical Research Council
  • ECMC
Investigators
Principal Investigator: Laura Kenny Imperial College London