Status:
UNKNOWN
The Value of 18F-FES-PET/CT in Predicting Fulvestrant Efficacy in Breast Cancer
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Conditions:
Estrogen Receptor-positive Breast Cancer
Fulvestrant
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
This study is focused on the value of 18F-FES-PET in predicting the Fulvestrant efficacy in hormone receptor-positive breast cancer. The imaging agent involved in this study is 16α-\[18F\]-fluoro-17β-...
Detailed Description
This study is an open, multi-center and prospective clinical study, It is the first time investigators are examining this imaging agent in Chinese patients with breast cancer. The Chinese FDA has app...
Eligibility Criteria
Inclusion
- Be at least 18 years or older (required for legal consent)
- Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- Pathologically diagnosed metastatic breast cancer
- Fulvestrant used as the first-line treatment
- Have primary breast tumor that is at least 2 cm in diameter as measured in any dimension on either mammogram, ultrasound, or breast MRI
- Have the ability to understand and the willingness to sign a written informed consent document.
Exclusion
- General Exclusion Criteria
- Previously treated metastatic breast cancer
- Concurrent malignancy of any type
- Impaired elimination (as defined as having problems with urination)
- Participation in a research study/studies involving radiation exposure within the past 12 months
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, major kidney or liver disease, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnancy
- Currently lactating (either breast feeding or breast pumping)
- General PET/CT Safety
Key Trial Info
Start Date :
March 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2019
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03768479
Start Date
March 5 2017
End Date
March 1 2019
Last Update
December 11 2018
Active Locations (1)
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1
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061