FDG PET/CT in Breast Cancer Bone Mets
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/30/2018 |
| Start Date: | September 2013 |
| End Date: | July 2019 |
| Contact: | Erin Schubert |
| Email: | erin.schubert@uphs.upenn.edu |
| Phone: | 215-573-6569 |
18F-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) for the Evaluation of Response to Therapy in Bone-dominant Metastatic Breast Cancer
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.
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.
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.
test, an FDG PET/CT study performed at 4 weeks after starting new hormone treatment.
Inclusion Criteria:
1. Adult patients, at least 18 years of age, with a history of pathologically confirmed
ER+ breast cancer
2. Biopsy proven or clinically obvious documented bone metastases from breast cancer
(with the majority of the disease burden in the bone)
3. Patients planning to start new endocrine targeted therapy (any line of therapy is
acceptable and any endocrine therapy is allowed)
4. Willing and able to comply with scheduled visits and serial imaging procedures
5. 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:
1. Women who are pregnant or breast feeding
2. Uncontrolled diabetes mellitus (fasting glucose greater than 200 mg/dL)
3. Inability to tolerate imaging procedures (e.g. claustrophobia, severe pain)
4. Weight exceeding capacity of imaging table
5. 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
Philadelphia, Pennsylvania 19104
Principal Investigator: David Mankoff, MD, PhD
Click here to add this to my saved trials
