18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) For The Evaluation Of Response To Therapy In Bone-Dominant Metastatic Breast Cancer

  • STATUS
    Recruiting
  • participants needed
    75
  • sponsor
    Abramson Cancer Center of the University of Pennsylvania
Updated on 8 November 2020

Summary

The purpose of this study is to assess the utility of FDG PET/CT in evaluating response of bone dominant breast cancer to therapy. Eligible patients with bone dominant ER+ breast cancer will undergo baseline FDG PET/CT for evaluation of their disease, after the start of therapy they will undergo an FDG PET/CT scan at 4 weeks and again at 12 weeks. PET/CT results will be compared to clinical measures of response, time to progression and overall survival.

Details
Condition Bone Dominant Metastatic ER+ Breast Cancer, Bone Dominant Metastatic ER+ Breast Cancer
Treatment FDG PET/CT, Fluorodeoxyglucose F 18 Injection (FDG)
Clinical Study IdentifierNCT02110160
SponsorAbramson Cancer Center of the University of Pennsylvania
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

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 6. 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 6. Treatment with marrow stimulating agents (e.g. granulocyte colony stimulating factor (GCSF)) within 3 weeks of baseline scan
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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