NCT01996046Completed
FDG PET/CT in Breast Cancer Bone Mets
18F-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) for the Evaluation of Response to Therapy in Bone-dominant Metastatic Breast Cancer
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 26 (actual)
- First submitted
- 8 Nov 2013
- Start date
- Sept 2013
- Primary completion date
- 31 Jul 2023
- Lead sponsor
- University of Pennsylvania
- Diseases
- Metastatic breast cancer
- NCT number
- NCT01996046
What you commit to
- Study type: Observational
- Participants enrolled: 26
- From Sept 2013 to the primary completion date, 31 Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with radiation or surgery to a significant percentage of bony metastatic sites
- Treatment with marrow stimulating agents (e.g. granulocyte colony stimulating factor (GCSF)) within 3 weeks of baseline scan
Lab values
- Uncontrolled diabetes mellitus (fasting glucose greater than 200 mg/dL)
Other
- Women who are pregnant or breast feeding
- Inability to tolerate imaging procedures (e.g. claustrophobia, severe pain)
- Weight exceeding capacity of imaging table
Who the study is looking for
- 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.
- Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pennsylvania Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.