FDG PET/CT in Breast Cancer Bone Mets

NCT ID: NCT01996046

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2026-07-31

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.

Conditions

Estrogen Receptor Positive Breast Cancer; Bone Metastases

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Bone mets

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

FDG PET/CT scan

Intervention Type: OTHER

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

Interventions

FDG PET/CT scan

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Mankoff, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC17113

Identifier Type: OTHER

Identifier Source: secondary_id

817940

Identifier Type: -

Identifier Source: org_study_id

NCT02110160

Identifier Type: -

Identifier Source: nct_alias