Estrogen Receptor Positive Breast CancerNCT01996046
FDG PET/CT in Breast Cancer Bone Mets
An observational study of Estrogen Receptor Positive Breast Cancer and Bone Metastases, run by University of Pennsylvania at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Estrogen Receptor Positive Breast Cancer, Bone Metastases
- What is being tested?
- FDG PET/CT scan
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 31 Jul 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a history of ER+ breast cancer with documented bone metastases from breast cancer. Patients must be planning to start new hormone therapy for their breast cancer.
Who may be able to join
- 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
Who cannot join
- 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
- Treatment with marrow stimulating agents (e.g. granulocyte colony stimulating factor (GCSF)) within 3 weeks of baseline scan
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- FDG PET/CT scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG PET/CT scanOther
[18F] FDG PET/CT scan at 4 weeks after starting new hormonal therapy
| Study group | Role | What they receive |
|---|---|---|
| Bone mets | Patients will undergo an [18F] FDG PET/CT scan at 4 weeks after starting new hormonal therapy Receives: Other: FDG PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Date of clinical progression will be recorded
Measured: medical record reviewed every 6 months from date of enrollment to date of progression, up to 120 months
Secondary outcomes (1)
Overall Survival
Date of death will be recorded
Measured: medical record reviewed every 6 months from date of enrollment to date of death, up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startSep 2013
- Primary completion31 Jul 2023
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Estrogen Receptor Positive Breast CancerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Mankoff, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996046
- Sponsor's protocol ID
- 817940
- Other IDs
- UPCC17113
- Status last verified
- Oct 2026
- First submitted
- 8 Nov 2013
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes