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Serial FES PET/CT to Measure Hormone Expression in Patients Undergoing Endocrine Targeted Therapy

Primary Purpose

Estrogen Receptor Positive, Primary or Recurrent Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

F-18 16 Alpha-Fluoroestradiol

Positron Emission Tomography

Computed Tomography

Fludeoxyglucose F-18

Positron Emission Tomography

Computed Tomography

Laboratory Biomarker Analysis

About this trial

This is an interventional diagnostic trial for Estrogen Receptor Positive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult, non-pregnant patients with biopsy-proven or clinically obvious primary, recurrent or metastatic breast cancer
Breast cancer from ER+ primary that is seen on other imaging tests. Tumor ER expression must have been confirmed by immunohistocytochemistry of primary tumor or recurrent disease.
At least one site of disease 1.5 cm or greater is needed to meet the spatial resolution limits of PET imaging.
Patients must have been off tamoxifen or other estrogen receptor blocking agents for at least 6 weeks and off chemotherapy for 3 weeks for the initial baseline FES.
Patients must be selected for an endocrine targeted therapy regimen for treatment of their breast cancer by the referring oncologist. Selected treatments may be part of experimental treatment protocols for which the patient would be separately consented.
Patients must be willing to undergo serial imaging procedures.
Patients must agree to allow access to clinical records regarding response to treatment and long term follow up.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

An inability to lie still for the tests
Individuals weighing more than 300 lb. (this is the weight limit of the scanner table)
Pregnant or lactating. Women of childbearing potential with either a positive or no pregnancy test at baseline are excluded.
Any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or clinically significant cardiac disease - congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia not well controlled with medication).
Use of tamoxifen, faslodex, DES or any other ER blocking agent < 6 weeks or chemotherapy < 3 weeks prior to imaging scan.
Uncontrolled diabetes mellitus (fasting glucose > 200 mg/dL)
Adult patients who require monitored anesthesia for PET scanning.

Sites / Locations

Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (F-18 FES PET/CT)

Arm Description

Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.

Outcomes

Primary Outcome Measures

Change in F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV) - Avg SULmax

FES uptake will be quantified using lean body mass adjusted SUV (SUL). Percentage change in FES average SULmax between baseline and a second FES scan will be calculated for up to 3 lesions per patient.

F-18 16 Alpha-fluoroestradiol (FES) Uptake

Quantitative measures of FES uptake for each disease site will be determined by drawing regions-of-interest on lesions to determine maximal FES uptake (SUVmax) per lesion. Up to 10 sites seen on the static torso survey will be quantified.

Proportion of Patients With a Threshold of Percentage Change, or That Surpass a Targeted Follow-up F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV)

The number of patients showing a 20% increase in FES uptake (SULmean or SUVmax) compared to baseline from the first to second scan using a 90% Wilson score binomial confidence interval.

Secondary Outcome Measures

Time to Disease Progression

Time to disease progression will be measured as the time from the start of endocrine therapy to the time the patient is first recorded as having disease progression.

Full Information

NCT ID

NCT04692103

First Posted

December 30, 2020

Last Updated

August 15, 2023

Sponsor

University of Washington

1. Study Identification

Unique Protocol Identification Number

NCT04692103

Brief Title

Serial FES PET/CT to Measure Hormone Expression in Patients Undergoing Endocrine Targeted Therapy

Official Title

Serial [F-18] Fluoroestradiol (FES) PET Imaging to Evaluate Endocrine-targeted Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 10, 2021 (Actual)

Primary Completion Date

October 1, 2021 (Actual)

Study Completion Date

April 30, 2041 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This clinical trial studies use of F-18 16 alpha-fluoroestradiol ([F-18] FES) positron emission tomography (PET)/computed tomography (CT) in measuring tumor hormone receptor expression in patients undergoing endocrine-targeted therapy for newly diagnosed breast cancer or breast cancer that has come back or spread to other places in the body. Comparing results of diagnostic procedures done before, during, and after hormone therapy may help measure a patient's response to treatment.

Detailed Description

OUTLINE: Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader. After completion of study, patients are followed up for up to 20 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Estrogen Receptor Positive, Primary or Recurrent Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic (F-18 FES PET/CT)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

F-18 16 Alpha-Fluoroestradiol

Other Intervention Name(s)

F-18 FES, FES, Fluorine-18 16 alpha-fluoroestradiol, Fluoroestradiol F-18

Intervention Description

Undergo F-18 FES PET/CT

Intervention Type

Procedure

Intervention Name(s)

Positron Emission Tomography

Other Intervention Name(s)

Medical Imaging, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography

Intervention Description

Undergo F-18 FES PET/CT

Intervention Type

Procedure

Intervention Name(s)

Computed Tomography

Other Intervention Name(s)

CAT Scan, Computerized Axial Tomography, CT scan

Intervention Description

Undergo F-18 FES PET/CT

Intervention Type

Drug

Intervention Name(s)

Fludeoxyglucose F-18

Other Intervention Name(s)

FDG, Fluorodeoxyglucose F18, 18FDG

Intervention Description

Undergo FDG PET/CT

Intervention Type

Procedure

Intervention Name(s)

Positron Emission Tomography

Other Intervention Name(s)

Medical Imaging, PET, PET Scan

Intervention Description

Undergo FDG PET/CT

Intervention Type

Procedure

Intervention Name(s)

Computed Tomography

Other Intervention Name(s)

CAT Scan

Intervention Description

Undergo FDG PET/CT

Intervention Type

Other

Intervention Name(s)

Laboratory Biomarker Analysis

Intervention Description

Correlative studies

Primary Outcome Measure Information:

Title

Change in F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV) - Avg SULmax

Description

Time Frame

From time of first F-18 FES-PET/CT scan to time of second F-18 FES-PET/CT scan (approximately 1-12 weeks)

Title

F-18 16 Alpha-fluoroestradiol (FES) Uptake

Description

Time Frame

From time of first F-18 FES-PET/CT scan to time of second F-18 FES-PET/CT scan (approximately 1-12 weeks)

Title

Proportion of Patients With a Threshold of Percentage Change, or That Surpass a Targeted Follow-up F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV)

Description

The number of patients showing a 20% increase in FES uptake (SULmean or SUVmax) compared to baseline from the first to second scan using a 90% Wilson score binomial confidence interval.

Time Frame

From time of first F-18 FES-PET/CT scan to time of second F-18 FES-PET/CT scan (approximately 1-12 weeks)

Secondary Outcome Measure Information:

Title

Time to Disease Progression

Description

Time to disease progression will be measured as the time from the start of endocrine therapy to the time the patient is first recorded as having disease progression.

Time Frame

From start of therapy up to 20 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult, non-pregnant patients with biopsy-proven or clinically obvious primary, recurrent or metastatic breast cancer Breast cancer from ER+ primary that is seen on other imaging tests. Tumor ER expression must have been confirmed by immunohistocytochemistry of primary tumor or recurrent disease. At least one site of disease 1.5 cm or greater is needed to meet the spatial resolution limits of PET imaging. Patients must have been off tamoxifen or other estrogen receptor blocking agents for at least 6 weeks and off chemotherapy for 3 weeks for the initial baseline FES. Patients must be selected for an endocrine targeted therapy regimen for treatment of their breast cancer by the referring oncologist. Selected treatments may be part of experimental treatment protocols for which the patient would be separately consented. Patients must be willing to undergo serial imaging procedures. Patients must agree to allow access to clinical records regarding response to treatment and long term follow up. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: An inability to lie still for the tests Individuals weighing more than 300 lb. (this is the weight limit of the scanner table) Pregnant or lactating. Women of childbearing potential with either a positive or no pregnancy test at baseline are excluded. Any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or clinically significant cardiac disease - congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia not well controlled with medication). Use of tamoxifen, faslodex, DES or any other ER blocking agent < 6 weeks or chemotherapy < 3 weeks prior to imaging scan. Uncontrolled diabetes mellitus (fasting glucose > 200 mg/dL) Adult patients who require monitored anesthesia for PET scanning.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hannah Linden

Organizational Affiliation

Fred Hutch/University of Washington Cancer Consortium

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fred Hutch/University of Washington Cancer Consortium

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Serial FES PET/CT to Measure Hormone Expression in Patients Undergoing Endocrine Targeted Therapy

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