NCT04006626

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 15, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2019

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

June 26, 2019

Last Update Submit

July 2, 2019

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Staging of breast cancer

    Deliver questionnaire to phycians to investigate the staging of BC according to AJCC 8 (TNM staging).

    6 weeks

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Patients with incomplete medical history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biyun Wang, MD

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Biyun Wang, Professor

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 26, 2019

First Posted

July 5, 2019

Study Start

February 15, 2019

Primary Completion

June 12, 2019

Study Completion

June 20, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations

CN(1)