FDG PET/CT in Breast Cancer Bone Mets

Active, not recruiting

• Conditions: Estrogen Receptor Positive Breast Cancer; Bone Metastases
• Interventions: Other: FDG PET/CT scan

• Registration Number: NCT01996046
• Lead Sponsor: University of Pennsylvania

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.

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-11-08
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-27
• Primary Completion: 2023-07-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 75

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Progression free survival	medical record reviewed every 6 months from date of enrollment to date of progression, up to 120 months	Date of clinical progression will be recorded

Secondary Outcome Measures

Name	Time	Method
Overall Survival	medical record reviewed every 6 months from date of enrollment to date of death, up to 120 months	Date of death will be recorded

Trial Locations

Locations (1)

University of Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States