NCT05541367

Brief Summary

18F-Fluoroestradiol (18F-FES) is an estrogen receptor-targeting positron emission tomography tracer with high sensitivity and specificity for the detection of estrogen receptor（ER）-positive tumors . 18F-FES has been used as a predictive biomarker to demonstrate estrogen receptor heterogeneity , to evaluate the pharmacokinetics of estrogen receptor-targeted drugs ， to measure residual estrogen receptors during endocrine therapy and to determine biologically optimal doses of novel estrogen receptor-targeted drugs .This study aimes to explore the efficacy of 18F-FES PET/CT in evaluating the expression levels of ER in primary and metastatic breast cancer patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Dec 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Dec 2021Dec 2026

Study Start

First participant enrolled

December 31, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

5 years

First QC Date

September 12, 2022

Last Update Submit

September 12, 2022

Conditions

Breast CancerTNBC - Triple-Negative Breast CancerEstrogen-receptor-negative Breast Cancer

Keywords

Estrogen receptorPET/CTbreast cancer

Outcome Measures

Primary Outcomes (1)

  • SUVmax

    SUVmax

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients should be more than 18 years old,and have been pathologically confirmed breast cancer.

You may qualify if:

  • More than 18 years old
  • Patients with pathologically confirmed breast cancer
  • Sign the informed consent form

You may not qualify if:

  • Pregnant women
  • Severe underlying diseases that cannot cooperate with PET examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TongjiHospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • ZHU XIAOHUA, DR

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ZHU XIAOHUA, DR

CONTACT

13971513770evazhu@vip.sina.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2022

First Posted

September 15, 2022

Study Start

December 31, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 15, 2022

Record last verified: 2022-09

Locations

CN(1)