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

Running, not enrolling · Phase 1

Conditions studied: Breast Neoplasm, Metastatic Breast Cancer, Rb+ Breast Cancer

In brief

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).

Key facts

Study ID

NCT02608216

Run by

University of Pennsylvania

People needed

20

Starts

2015-11-01

Expected to finish

2026-11-01

Last updated by the study team

2025-09-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age
• 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)
• Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
• Patients must be candidates to receive treatment on the therapeutic trial UPCC06115, a Phase I study of ribociclib (LEE011) and weekly paclitaxel.

You may not qualify if…

• 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.
• Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
• 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

Where it is running

• University of Pennsylvania Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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