Characterizing Breast Cancer With 18F-FES PET/CT
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
18F-FES PET/CT scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria: suspected or confirmed metastatic ER-positive breast cancer; 18F-FDG PET/CT within two weeks; signed written consent. Exclusion Criteria: pregnancy; breastfeeding; any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18F-FES PET/CT
Arm Description
Inject 18F-FES and then perform PET/CT scan.
Outcomes
Primary Outcome Measures
Standardized uptake value of 18F-FES in BC
The max standard uptake value (SUVmax) was measured in the breast cancer lesions on 18F-FES PET/CT.
Lesions detected by 18F-FES PET/CT
The number of target lesions was calculated by 18F-FES PET/CT.
Compared with 18F-FDG PET/CT
The number of lesions detected by 18F-FES PET/CT was compared with 18F-FDG PET/CT.
Secondary Outcome Measures
Overall survival
Evaluate overall survival (OS) in patients receiving regimens containing endocrine therapy
Full Information
NCT ID
NCT05613270
First Posted
November 4, 2022
Last Updated
November 4, 2022
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05613270
Brief Title
Characterizing Breast Cancer With 18F-FES PET/CT
Official Title
A Prospective Pilot Study to Explore Performance and Efficacy of 18F-FES PET/CT in ER-positive Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
18F-fluoroestradiol (FES) is radioactive labeled estradiol, developed for in vivo visualization of estrogen receptor (ER) using positron emission tomography (PET). In this prospective study, 18F-FES PET/CT will be used to evaluate ER activity of metastatic disease and their potential sensitivity to endocrine therapy in ER-positive breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
18F-FES PET/CT
Arm Type
Experimental
Arm Description
Inject 18F-FES and then perform PET/CT scan.
Intervention Type
Diagnostic Test
Intervention Name(s)
18F-FES PET/CT scan
Intervention Description
Patients with suspected metastatic ER-positive breast cancer underwent 18F-FES PET/CT after an injection of 185-222 MBq (5-6 mCi) 18F-FES to image lesions of metastatic breast cancer.
Primary Outcome Measure Information:
Title
Standardized uptake value of 18F-FES in BC
Description
The max standard uptake value (SUVmax) was measured in the breast cancer lesions on 18F-FES PET/CT.
Time Frame
through study completion, an average of 1 year
Title
Lesions detected by 18F-FES PET/CT
Description
The number of target lesions was calculated by 18F-FES PET/CT.
Time Frame
through study completion, an average of 1 year
Title
Compared with 18F-FDG PET/CT
Description
The number of lesions detected by 18F-FES PET/CT was compared with 18F-FDG PET/CT.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Overall survival
Description
Evaluate overall survival (OS) in patients receiving regimens containing endocrine therapy
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
suspected or confirmed metastatic ER-positive breast cancer;
18F-FDG PET/CT within two weeks;
signed written consent.
Exclusion Criteria:
pregnancy;
breastfeeding;
any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhixin Hao, M.D.
Phone
+86-18401649136
Email
zxhaonm@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li Huo, M.D.
Phone
+86-13910801986
Email
huoli@pumch.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Huo, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhixin Hao, M.D.
Phone
+86-18401649136
Email
zxhaonm@outlook.com
First Name & Middle Initial & Last Name & Degree
Li Huo, M.D.
Phone
+86-13910801986
Email
huoli@pumch.cn
First Name & Middle Initial & Last Name & Degree
Li Huo, M.D.
12. IPD Sharing Statement
Learn more about this trial
Characterizing Breast Cancer With 18F-FES PET/CT
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