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

Stage IV Breast Cancer AJCC v6 and v7 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04692103
• Other study ID #: RG1007834
• Secondary ID: 10465
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 10, 2021
• Est. completion date: April 30, 2041

Study information

• Verified date: March 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2
• Est. completion date: April 30, 2041
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• F-18 16 Alpha-Fluoroestradiol
Undergo F-18 FES PET/CT

Procedure:
• Positron Emission Tomography
Undergo F-18 FES PET/CT
• Computed Tomography
Undergo F-18 FES PET/CT

Drug:
• Fludeoxyglucose F-18
Undergo FDG PET/CT

Procedure:
• Positron Emission Tomography
Undergo FDG PET/CT
• Computed Tomography
Undergo FDG PET/CT

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From time of first F-18 FES-PET/CT scan to time of second F-18 FES-PET/CT scan (approximately 1-12 weeks)
Primary	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.	From time of first F-18 FES-PET/CT scan to time of second F-18 FES-PET/CT scan (approximately 1-12 weeks)
Primary	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.	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	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.	From start of therapy up to 20 years