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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
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
November 4, 2022
Last Updated
November 4, 2022
Sponsor
Peking Union Medical College Hospital
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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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