Characterizing Breast Cancer With 18F-FES PET/CT

NCT ID: NCT05613270

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-FES PET/CT

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

Group Type EXPERIMENTAL

18F-FES PET/CT scan

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Huo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhixin Hao, M.D.

Role: CONTACT

+86-18401649136

Li Huo, M.D.

Role: CONTACT

+86-13910801986

Facility Contacts

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Zhixin Hao, M.D.

Role: primary

+86-18401649136

Li Huo, M.D.

Role: backup

+86-13910801986

Other Identifiers

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PekingUMCH-FES-BC-1

Identifier Type: -

Identifier Source: org_study_id

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