Bone Dominant Metastatic ER+ Breast Cancer Clinical Trial
Official title:
18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) For The Evaluation Of Response To Therapy In Bone-Dominant Metastatic Breast Cancer
| NCT number | NCT02110160 |
| Other study ID # | UPCC 17113 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 2013 |
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.
| Status | Recruiting |
| Enrollment | 75 |
| Est. completion date | |
| Est. primary completion date | September 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Adverse Events | 2 years |