Status:
UNKNOWN
18F-fluoroestradiol (FES) PET/CT for Breast Cancer
Lead Sponsor:
Hoag Memorial Hospital Presbyterian
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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-fluoroest...
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 Natio...
Eligibility Criteria
Inclusion
- 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
- 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 Thus, exclusion criteria specify that patients must be withdrawn from Selective ER Modifiers for at least 8 weeks and withdrawn from Selective ER Degraders for for least 24 weeks prior to performance of the FES PET/CT.
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2023
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04883814
Start Date
January 15 2021
End Date
December 15 2023
Last Update
September 28 2023
Active Locations (1)
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1
Hoag Memorial Hospital Presbyterian
Irvine, California, United States, 92614