Clinical Trial · NCT02608216

[18F]FLT PET/CT in Rb+ Metastatic Breast Cancer

Overview

In this study positron emission tomography (PET/CT) imaging will be used to evaluate proliferative activity in sites of metastatic disease using the investigational radiotracer \[18F\]fluorothymidine (FLT).

Sponsor

University of Pennsylvania

Phase

Phase 1

Contacts

David Mankoff, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02608216

Eligibility

Inclusion

History of histologically or cytologically confirmed breast cancer, any ER, PR or HER2 status is allowed as long as it expresses the Rb protein.
At least one site of metastatic breast cancer that is outside of the liver and bone that is identified by standard imaging (e.g. CT, MRI, FDG PET/CT, ultrasound, x-ray)
Patients must be candidates to receive treatment on the therapeutic trial UPCC06115, a Phase I study of ribociclib (LEE011) and weekly paclitaxel.

Exclusion

Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
Ineligible for the therapeutic trial UPCC 06115
Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
Females who are pregnant at the time of screening will not be eligible for this study, urine pregnancy test will be performed at screening in women of child-bearing potential.