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



Status:Recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/30/2018
Start Date:September 2013
Contact:David A. Mankoff, MD
Email:PennCancerTrials@emergingmed.com
Phone:855-216-0098

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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.


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
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Principal Investigator: David Mankoff, MD
Phone: 855-216-0098
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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Philadelphia, PA
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