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

August 23, 2023 updated by: University of Pennsylvania

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. At least 18 years of age
  2. History of histologically or cytologically confirmed breast cancer, any ER, PR or HER2 status is allowed as long as it expresses the Rb protein.
  3. 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)
  4. 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.
  5. Patients must be candidates to receive treatment on the therapeutic trial UPCC06115, a Phase I study of ribociclib (LEE011) and weekly paclitaxel.

Exclusion Criteria:

  1. 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.
  2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
  3. 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.
  4. Ineligible for the therapeutic trial UPCC 06115

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FLT PET/CT
All subjects will receive an [18F]FLT PET/CT scan.
Drug: [18F]FLT
[18F]FLT PET/CT scan, imaging tracer
Other Names:
  • [18F]fluorothymidine
Device: PET/CT
[18F]FLT PET/CT scan
Drug: ribociclib
therapeutic
Other Names:
  • LEE011
Drug: paclitaxel
therapeutic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measure changes in [18F]FLT uptake in metastatic tumors before and during treatment with ribociclib (LEE011) only and associate these changes with response to ribociclib (LEE011)/paclitaxel therapy.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure changes in [18F]FLT uptake in metastatic tumors during and after 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
Measure changes in [18F]FLT uptake in metastatic tumors during and after treatment with ribociclib (LEE011) only and associate these changes with response to ribociclib (LEE011)/paclitaxel therapy.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: David Mankoff, MD, PhD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

October 18, 2015

First Submitted That Met QC Criteria

November 17, 2015

First Posted (Estimated)

November 18, 2015

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 822997

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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