Clincosm LogoSign in Get a demo

Characterizing Breast Cancer With 18F-FES PET/CT

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05613270
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
44
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 18F-FES PET/CT scan
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Prospective Pilot Study to Explore Performance and Efficacy of 18F-FES PET/CT in ER-positive Breast Cancer Patients
Actual Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 18F-FES PET/CT

Inject 18F-FES and then perform PET/CT scan.

Diagnostic Test: 18F-FES PET/CT scan
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.

Outcome Measures

Primary Outcome Measures

  1. Standardized uptake value of 18F-FES in BC [through study completion, an average of 1 year]

    The max standard uptake value (SUVmax) was measured in the breast cancer lesions on 18F-FES PET/CT.

  2. Lesions detected by 18F-FES PET/CT [through study completion, an average of 1 year]

    The number of target lesions was calculated by 18F-FES PET/CT.

  3. Compared with 18F-FDG PET/CT [through study completion, an average of 1 year]

    The number of lesions detected by 18F-FES PET/CT was compared with 18F-FDG PET/CT.

Secondary Outcome Measures

  1. Overall survival [3 years]

    Evaluate overall survival (OS) in patients receiving regimens containing endocrine therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking Union Medical College Hospital Beijing Beijing China 100730

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Li Huo, M.D., Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT05613270
Other Study ID Numbers:
  • PekingUMCH-FES-BC-1
First Posted:
Nov 14, 2022
Last Update Posted:
Nov 14, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Nov 14, 2022