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

• ClinicalTrials.gov Identifier: NCT04692103
• Recruitment Status: Not yet recruiting
• First Posted: December 31, 2020
• Last Update Posted: March 3, 2021
• Sponsor: University of Washington
• Information provided by (Responsible Party): University of Washington

Tracking Information

• First Submitted Date: December 30, 2020
• First Posted Date: December 31, 2020
• Last Update Posted Date: March 3, 2021
• Estimated Study Start Date: April 1, 2021
• Estimated Primary Completion Date: April 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 30, 2020)

• Change in F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV), assessed by a one-sample test of the percent Change in FES SUV [ Time Frame: From time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 1-12 weeks) ]
  FES uptake will be quantified using lean body mass adjusted SUV (SULmean). The geometric mean will be calculated for up to 3 lesions per patient. Systematic change in FES SULgmean between baseline and a second FES scan measured using a sign test where the median change is zero.
• F-18 16 alpha-fluoroestradiol (FES) uptake [ Time Frame: From time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 1-12 weeks) ]
  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. Lesions will be qualitatively determined to be visible or not visible.
• 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) [ Time Frame: From time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 1-12 weeks) ]
  The number of patients showing a 20% increase in FES uptake (SULgmean or SUVmax) compared to baseline from the first to second or third scan using a 90% Wilson score binomial confidence interval.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 30, 2020)

Time to Disease Progression [ Time Frame: From start of therapy up to 20 years ]

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• 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
  Other Names:

  • F-18 FES
  • FES
  • Fluorine-18 16 alpha-fluoroestradiol
  • Fluoroestradiol F-18
• Procedure: Positron Emission Tomography
  Undergo F-18 FES PET/CT
  Other Names:

  • Medical Imaging
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
• Procedure: Computed Tomography
  Undergo F-18 FES PET/CT
  Other Names:

  • CAT Scan
  • Computerized Axial Tomography
  • CT scan
• Drug: Fludeoxyglucose F-18
  Undergo FDG PET/CT
  Other Names:

  • FDG
  • Fluorodeoxyglucose F18
  • 18FDG
• Procedure: Positron Emission Tomography
  Undergo FDG PET/CT
  Other Names:

  • Medical Imaging
  • PET
  • PET Scan
• Procedure: Computed Tomography
  Undergo FDG PET/CT
  Other Name: CAT Scan
• Other: Laboratory Biomarker Analysis
  Correlative studies

Study Arms

Experimental: Diagnostic (F-18 FES PET/CT)

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.

Interventions:

• Drug: F-18 16 Alpha-Fluoroestradiol
• Procedure: Positron Emission Tomography
• Procedure: Computed Tomography
• Drug: Fludeoxyglucose F-18
• Procedure: Positron Emission Tomography
• Procedure: Computed Tomography
• Other: Laboratory Biomarker Analysis

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: December 30, 2020): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 30, 2041
• Estimated Primary Completion Date: April 30, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Hannah Linden; 206 606-6710; hmlinden@uw.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04692103
• Other Study ID Numbers: RG1007834; 10465 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: University of Washington
• Study Sponsor: University of Washington
• Collaborators: Not Provided

Investigators

• Principal Investigator: Hannah Linden; Fred Hutch/University of Washington Cancer Consortium

• PRS Account: University of Washington
• Verification Date: December 2020