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

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

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.

Condition or disease Intervention/treatment Phase
Estrogen Receptor Positive Primary or Recurrent Breast Carcinoma Stage IV Breast Cancer AJCC v6 and v7 Drug: F-18 16 Alpha-Fluoroestradiol Procedure: Positron Emission Tomography Procedure: Computed Tomography Drug: Fludeoxyglucose F-18 Other: Laboratory Biomarker Analysis Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Serial [F-18] Fluoroestradiol (FES) PET Imaging to Evaluate Endocrine-targeted Therapy
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2041

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04692103


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

Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Contact: Hannah Linden    206-606-6710    hmlinden@uw.edu   
Principal Investigator: Hannah Linden         
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Hannah Linden Fred Hutch/University of Washington Cancer Consortium
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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT04692103    
Other Study ID Numbers: RG1007834
10465 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action