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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT02608216
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [18F]FLT — DRUG
    \[18F\]FLT PET/CT scan, imaging tracer
  • PET/CT — DEVICE
    \[18F\]FLT PET/CT scan
  • ribociclib — DRUG
    therapeutic
  • paclitaxel — DRUG
    therapeutic

Study Details

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 Dates

Start date
Nov 30, 2015
Status verified
Sep 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: FLT PET/CT
    All subjects will receive an \[18F\]FLT PET/CT scan.

Primary Outcome Measure

Measure changes in [18F]FLT uptake in metastatic tumors before and during treatment with ribociclib (LEE011) only, patient will have FLT PET/CT scan at baseline, run-in day -3, and cycle 1, day 1 of ribociclib (LEE011)/paclitaxel therapy [ Time Frame: 4 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pennsylvania HospitalPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Pennsylvania Hospital· Philadelphia, PA

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