NCT05392985

Brief Summary

To investigate the treatment pattern and efficacy of MBC patients with ER heterogeneity using a novel convenient way of 18F-fluoroestradiol positron emission tomography/computed tomography (18F-FES PET/CT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

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

January 15, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

11 months

First QC Date

May 23, 2022

Last Update Submit

February 23, 2024

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • PFS

    Progression free survival

    6 weeks

Secondary Outcomes (1)

  • Adverse events

    6 weeks

Study Arms (1)

FES+-

MBC patients with both FES positive(+) and negative(-) lesions.

Eligibility Criteria

Age18 Years+
Sexfemale
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 received 18F-FES PET/CT in Fudan University Shanghai Cancer Center from 2017-2021.
  • Patients had both FES positive (FES+) and negative (FES-) lesions in FES exam.
  • Patients received further treatment.

You may not qualify if:

  • Incomplete medical records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

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

    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

May 23, 2022

First Posted

May 26, 2022

Study Start

January 15, 2022

Primary Completion

December 15, 2022

Study Completion

December 15, 2022

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations

CN(1)