Back to results18F-fluoroestradiol (FES) PET/CT for Breast Cancer
Primary Purpose
Breast Cancer
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
18F-fluoroestradiol PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring 18F-fluoroestradiol, Breast Cancer, PET/CT, Staging
Eligibility Criteria
Inclusion Criteria:
- Female ≥ 18 years of age.
- Histologically confirmed ER-positve breast cancer. Any pathology from a primary or metastatic breast cancer site demonstrating ER-positivity will be allowed.
- ECOG performance status 0 to 2
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
Either:
- For cohort 1: Stage 2B-3C locally advanced disease and plan for CT/bone scan systemic staging or
- For cohort 2: Suspected recurrent disease and plan for CT/bone scan systemic staging
Exclusion Criteria:
- Pregnant or breastfeeding
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
- Selective ER Modulators (SERMs) such as tamoxifen and Selective ER Degraders (SERDs) such as fulvestrant may reduce detection of ER-positive lesions by FES. Thus, exclusion criteria specify that patients must be withdrawn from Selective ER Modifiers for at least 8 weeks and withdrawn from Selective ER Degraders for for least 24 weeks prior to performance of the FES PET/CT.
Sites / Locations
- Hoag Memorial Hospital Presbyterian
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Initial Staging
Suspected disease recurrence
Arm Description
FES PET/CT will be compared to CT/bone scan for detection of unsuspected distant metastases in patients with ER-positive locally advanced breast cancer
FES PET/CT will be compared to CT/bone scan for detection of unsuspected distant metastases in patients with ER-positive breast cancer and suspected disease recurrence
Outcomes
Primary Outcome Measures
Detection of unsuspected distant metastases
FES PET/CT will be compared against standard of care CT/bone scan for detection of unsuspected distant metastases in patients with ER+ locally advanced disease
Secondary Outcome Measures
Detection of suspected disease recurrence
FES PET/CT will be compared against standard of care CT/bone scan for detection of unsuspected distant metastases in patients with ER+ breast cancer and suspected disease recurrence
Full Information
NCT ID
NCT04883814
First Posted
May 7, 2021
Last Updated
September 25, 2023
Sponsor
Hoag Memorial Hospital Presbyterian
1. Study Identification
Unique Protocol Identification Number
NCT04883814
Brief Title
18F-fluoroestradiol (FES) PET/CT for Breast Cancer
Official Title
18F-fluoroestradiol (FES) PET/CT Compared To Standard-of-Care Imaging In Patients With Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hoag Memorial Hospital Presbyterian
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The standard of care imaging of breast cancer metastases recommended by the National Comprehensive Cancer Network (NCCN), CT of the chest/abdomen/pelvis and bone scan, may be suboptimal. 18F-fluoroestradiol (FES) is a novel PET tracer designed to detect estrogen receptors, which are often expressed in breast cancers. FES PET/CT may provide improved evaluation of metastases in patients with ER-positive breast cancer.
Detailed Description
This will be a phase II clinical trial to assess the clinical value of FES for staging and detection of disease recurrence in patients with ER-positive breast cancer, in direct comparison to the National Comprehensive Cancer Network's (NCCN) recommended standard-of-care using CT of the chest/abdomen/pelvis and bone scan [2].
Two cohorts will be evaluated:
Patients with advanced local breast cancer that will undergo standard of care imaging (CT + bone scan) to evaluate for unsuspected distant metastases.
Patients with suspicion for breast cancer recurrence that will undergo standard of care imaging (CT + bone scan) to evaluate for disease recurrence.
In both cohorts, FES PET/CT will be obtained, and compared with standard of care imaging. Whether on standard of care imaging or the research FES PET/CT, lesions suspicious for unsuspected distant metastases (cohort 1) or the site of disease recurrence (cohort 2) will be selected for biopsy, as is clinically standard of care to confirm disease that would alter patient management. Pathology will be used as the reference standard for confirming malignancy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
18F-fluoroestradiol, Breast Cancer, PET/CT, Staging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
124 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Initial Staging
Arm Type
Experimental
Arm Description
FES PET/CT will be compared to CT/bone scan for detection of unsuspected distant metastases in patients with ER-positive locally advanced breast cancer
Arm Title
Suspected disease recurrence
Arm Type
Experimental
Arm Description
FES PET/CT will be compared to CT/bone scan for detection of unsuspected distant metastases in patients with ER-positive breast cancer and suspected disease recurrence
Intervention Type
Diagnostic Test
Intervention Name(s)
18F-fluoroestradiol PET/CT
Other Intervention Name(s)
FES PET/CT
Intervention Description
Estrogen receptor targeted imaging
Primary Outcome Measure Information:
Title
Detection of unsuspected distant metastases
Description
FES PET/CT will be compared against standard of care CT/bone scan for detection of unsuspected distant metastases in patients with ER+ locally advanced disease
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
Detection of suspected disease recurrence
Description
FES PET/CT will be compared against standard of care CT/bone scan for detection of unsuspected distant metastases in patients with ER+ breast cancer and suspected disease recurrence
Time Frame
up to 4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female ≥ 18 years of age.
Histologically confirmed ER-positve breast cancer. Any pathology from a primary or metastatic breast cancer site demonstrating ER-positivity will be allowed.
ECOG performance status 0 to 2
Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
Either:
For cohort 1: Stage 2B-3C locally advanced disease and plan for CT/bone scan systemic staging or
For cohort 2: Suspected recurrent disease and plan for CT/bone scan systemic staging
Exclusion Criteria:
Pregnant or breastfeeding
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
Selective ER Modulators (SERMs) such as tamoxifen and Selective ER Degraders (SERDs) such as fulvestrant may reduce detection of ER-positive lesions by FES. Thus, exclusion criteria specify that patients must be withdrawn from Selective ER Modifiers for at least 8 weeks and withdrawn from Selective ER Degraders for for least 24 weeks prior to performance of the FES PET/CT.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Ulaner, MD, PhD
Organizational Affiliation
Hoag Family Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hoag Memorial Hospital Presbyterian
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
18F-fluoroestradiol (FES) PET/CT for Breast Cancer
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