FDG PET/CT in Breast Cancer Bone Mets | NCT01996046

Studies
FDG PET/CT in Breast Cancer Bone Mets

NCT01996046

Sponsor

University of Pennsylvania

Status

Active, not recruiting

Last Update Posted

Sep 2, 2025Actual

Enrollment

75Estimated

Phase

Not provided

Conditions

Estrogen Receptor Positive Breast Cancer
Bone Metastases

Interventions

FDG PET/CT scan

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UPCC17113	Other Identifier	Penn cancer center

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Jul 31, 2023Actual

Completion Date

Jul 31, 2026Estimated

First Submitted Date

Nov 8, 2013

First Submission Date that Met QC Criteria

Nov 21, 2013

First Posted Date

Nov 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2025

Last Update Posted Date

Sep 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
FDG PET/CT scan	Other	[18F] FDG PET/CT scan at 4 weeks after starting new hormonal therapy	Bone mets

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample