FDG PET/CT in Breast Cancer Bone Mets

NCT01996046 | Active Not Recruiting DMC

• 2 other identifiers: 817940UPCC17113
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Estrogen Receptor Positive Breast Cancer; Bone Metastases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall Survival

  medical record reviewed every 6 months from date of enrollment to date of death, up to 120 months

Other Outcomes (1)

• Number of patients who have a Skeletal Related Event

  medical record reviewed every 6 months from date of enrollment to date of death, up to 120 months

Study Arms (1)

Bone mets

Patients will undergo an \[18F\] FDG PET/CT scan at 4 weeks after starting new hormonal therapy

Other: FDG PET/CT scan

Interventions

FDG PET/CT scan OTHER

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

Bone mets

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• David Mankoff, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: November 27, 2013
• Study Start: September 1, 2013
• Primary Completion: July 31, 2023
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

US (1)