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Active, Not Recruiting

NCT Number: NCT01996046

FDG PET/CT in Breast Cancer Bone Mets

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Estrogen Receptor Positive Breast Cancer Bone Metastases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

FDG PET/CT scan

Other

[18F] FDG PET/CT scan at 4 weeks after starting new hormonal therapy

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2023
Study completion
2026
First posted
Nov 27, 2013
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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