FDG PET/CT in Breast Cancer Bone Mets

Bone Metastases 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01996046
• Other study ID #: 817940
• Secondary ID: UPCC17113
• Status: Active, not recruiting
• Start date: September 2013
• Est. completion date: July 2024

Study information

• Verified date: December 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Other known NCT identifiers

• NCT02110160

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: July 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Metastases
• Breast Neoplasms
• Estrogen Receptor Positive Breast Cancer

Intervention

Other:
• FDG PET/CT scan
[18F] FDG PET/CT scan at 4 weeks after starting new hormonal therapy

Locations

Country	Name	City	State
United States	University of Pennsylvania Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients who have a Skeletal Related Event	Occurrence of radiation therapy to stabilize skeletal disease, pathologic fracture,spinal cord compression, surgery to stabilize the skeleton or hypercalcemia of malignancy will be recorded	medical record reviewed every 6 months from date of enrollment to date of death, up to 120 months
Primary	Progression free survival	Date of clinical progression will be recorded	medical record reviewed every 6 months from date of enrollment to date of progression, up to 120 months
Secondary	Overall Survival	Date of death will be recorded	medical record reviewed every 6 months from date of enrollment to date of death, up to 120 months