FDG PET/CT in Breast Cancer Bone Mets

August 29, 2025 updated by: University of Pennsylvania

18F-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) for the Evaluation of Response to Therapy in Bone-dominant Metastatic Breast Cancer

This study will evaluate baseline uptake on a FDG PET/CT scan in patients with breast cancer that has spread to the bones. A repeat FDG PET/CT scan will be done 4 weeks after the start of new breast cancer hormone treatment and again at 12 weeks after treatment start. The baseline uptake and change in uptake after the repeat scans will be compared to clinical long term outcomes such as time to progression and overall survival. In addition the uptake will be compared to the incidence of skeletal related events that are common occurrences in patients with cancer that has spread to the bones.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an observational study as all patients will receive the same research diagnostic test, an FDG PET/CT study performed at 4 weeks after starting new hormone treatment.

Study Type

Observational

Enrollment (Estimated)

75

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with a history of ER+ breast cancer with documented bone metastases from breast cancer. Patients must be planning to start new hormone therapy for their breast cancer.

Description

Inclusion Criteria:

  1. Adult patients, at least 18 years of age, with a history of pathologically confirmed ER+ breast cancer
  2. Biopsy proven or clinically obvious documented bone metastases from breast cancer (with the majority of the disease burden in the bone)
  3. Patients planning to start new endocrine targeted therapy (any line of therapy is acceptable and any endocrine therapy is allowed)
  4. Willing and able to comply with scheduled visits and serial imaging procedures
  5. Agrees to allow access to clinical records regarding response to treatment and long term follow up.
  6. Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria:

  1. Women who are pregnant or breast feeding
  2. Uncontrolled diabetes mellitus (fasting glucose greater than 200 mg/dL)
  3. Inability to tolerate imaging procedures (e.g. claustrophobia, severe pain)
  4. Weight exceeding capacity of imaging table
  5. Previous treatment with radiation or surgery to a significant percentage of bony metastatic sites
  6. Treatment with marrow stimulating agents (e.g. granulocyte colony stimulating factor (GCSF)) within 3 weeks of baseline scan

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bone mets
Patients will undergo an [18F] FDG PET/CT scan at 4 weeks after starting new hormonal therapy
Other: FDG PET/CT scan
[18F] FDG PET/CT scan at 4 weeks after starting new hormonal therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: medical record reviewed every 6 months from date of enrollment to date of progression, up to 120 months
Date of clinical progression will be recorded
medical record reviewed every 6 months from date of enrollment to date of progression, up to 120 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: medical record reviewed every 6 months from date of enrollment to date of death, up to 120 months
Date of death will be recorded
medical record reviewed every 6 months from date of enrollment to date of death, up to 120 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who have a Skeletal Related Event
Time Frame: medical record reviewed every 6 months from date of enrollment to date of death, up to 120 months
Occurrence of radiation therapy to stabilize skeletal disease, pathologic fracture,spinal cord compression, surgery to stabilize the skeleton or hypercalcemia of malignancy will be recorded
medical record reviewed every 6 months from date of enrollment to date of death, up to 120 months

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

September 1, 2013

Primary Completion (Actual)

July 31, 2023

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

November 8, 2013

First Submitted That Met QC Criteria

November 21, 2013

First Posted (Estimated)

November 27, 2013

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 817940
  • UPCC17113 (Other Identifier: Penn cancer center)

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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