FDG PET/CT in Breast Cancer Bone Mets
- Conditions
- Estrogen Receptor Positive Breast CancerBone Metastases
- Registration Number
- NCT01996046
- Lead Sponsor
- University of Pennsylvania
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- 75
Inclusion Criteria:<br><br> 1. Adult patients, at least 18 years of age, with a history of pathologically confirmed<br> ER+ breast cancer<br><br> 2. Biopsy proven or clinically obvious documented bone metastases from breast cancer<br> (with the majority of the disease burden in the bone)<br><br> 3. Patients planning to start new endocrine targeted therapy (any line of therapy is<br> acceptable and any endocrine therapy is allowed)<br><br> 4. Willing and able to comply with scheduled visits and serial imaging procedures<br><br> 5. Agrees to allow access to clinical records regarding response to treatment and long<br> term follow up.<br><br> 6. Be informed of the investigational nature of this study and provide written informed<br> consent in accordance with institutional and federal guidelines<br><br>Exclusion Criteria:<br><br> 1. Women who are pregnant or breast feeding<br><br> 2. Uncontrolled diabetes mellitus (fasting glucose greater than 200 mg/dL)<br><br> 3. Inability to tolerate imaging procedures (e.g. claustrophobia, severe pain)<br><br> 4. Weight exceeding capacity of imaging table<br><br> 5. Previous treatment with radiation or surgery to a significant percentage of bony<br> metastatic sites<br><br> 6. Treatment with marrow stimulating agents (e.g. granulocyte colony stimulating factor<br> (GCSF)) within 3 weeks of baseline scan
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method Overall Survival