NCT02608216

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

[18F]Fluorothymidine (FLT) PET/CT Imaging in Rb+ Metastatic Breast Cancer Patients Undergoing LEE011 and Weekly Paclitaxel Therapy

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This protocol is designed to develop relationships between parameters determined from imaging biomarker studies and ones used for determination of therapeutic response to combined CDK4 Inhibitor and chemotherapy regimens. Imaging will occur prior to starting therapy on the separate therapeutic protocol UPCC 06115. Patients may undergo a second FLT PET/CT scan following a 3-day run of ribociclib (LEE011) (day -6 to -4) and a third FLT PET/CT scan on cycle 1 day 12 following two treatments of weekly Paclitaxel to compare changes in FLT uptake measures.

Conditions

• Breast Neoplasm
• Metastatic Breast Cancer
• Rb+ Breast Cancer

Interventions

Type	Name	Description
DRUG	[18F]FLT	\[18F\]FLT PET/CT scan, imaging tracer
DEVICE	PET/CT	\[18F\]FLT PET/CT scan
DRUG	ribociclib	therapeutic
DRUG	paclitaxel	therapeutic

Timeline

• Start date: 2015-11-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2015-11-18
• Last updated: 2025-09-03

Locations

1 site across 1 country: United States