18F-FES PET/CT's Additional Clinical Value in ER+ BC

July 2, 2019 updated by: Biyun Wang, MD, Fudan University

18F-FES PET/CT Influences the Staging and Management of Newly Diagnosed Oestrogen Receptor-Positive Breast Cancer Patients: A Retrospective Comparative Study With 18F-FDG PET/CT

To figure out whethetr 18F-FES PET/CT could influence the staging and management of newly diagnosed Oestrogen Receptor-positive Breast Cancer Patients.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Biyun Wang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage

Description

Inclusion Criteria:

  • Patients with newly diagnosed immunohistochemical confirmed oestrogen receptor (ER)-positive breast cancer
  • Patients underwent both 18F-FES PET/CT and 18F-FDG PET/CT in Fudan University Shanghai Cancer Center within 1 week after diagnosis
  • Patients with available medical history

Exclusion Criteria:

  • Patients with incomplete medical history

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
PET group
the staging and management of newly diagnosed ER+ Breast Cancer Patients based on 18F-FDG PET/CT
FES group
the staging and management of newly diagnosed ER+ Breast Cancer Patients based on 18F-FDG PET/CT and 18F-FES PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Staging of breast cancer
Time Frame: 6 weeks
Deliver questionnaire to phycians to investigate the staging of BC according to AJCC 8 (TNM staging).
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2019

Primary Completion (Actual)

June 12, 2019

Study Completion (Actual)

June 20, 2019

Study Registration Dates

First Submitted

June 26, 2019

First Submitted That Met QC Criteria

July 2, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YOUNGBC-7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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