Negative ER Expression Assessed by 18F-FES PET/CT in the... | NCT05797987

Studies
Negative ER Expression Assessed by 18F-FES PET/CT in the MBC With ER-positive Primary Tumor

NCT05797987

Sponsor

Fudan University

Status

Completed

Last Update Posted

Feb 26, 2024Actual

Enrollment

52Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2022Actual

Primary Completion Date

Aug 1, 2023Actual

Completion Date

Aug 1, 2023Actual

First Submitted Date

Mar 22, 2023

First Submission Date that Met QC Criteria

Mar 22, 2023

First Posted Date

Apr 4, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2024

Last Update Posted Date

Feb 26, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FES negative in MBC		Patients who did not present with any ER-positive lesions were characterized as with negative ER expression in the metastatic stage

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression free survival (PFS)		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Adverse events	Number of participants with treatment-related adverse events as assessed by CTCAE v 5.0	6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with breast cancer (according to International Classification of Diseases 10th Revision) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.
MBC patients who underwent 18F-FES PET/CT at the Fudan University Shanghai Cancer Center between 2010 and 2022
Patients diagnosed with primary ER-positive tumor and who were yet to receive any systemic therapy during the advanced stage

Exclusion Criteria:

Patients with incomplete medical records and those diagnosed with secondary primary tumors

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

MBC patients with ER-positive primary tumor who detected negative ER expression in metastatic disease using 18F-FES PET/CT at the Fudan University Shanghai Cancer Center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Biyun Wang, MD		Shanghai	Shanghai Municipality	200032	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38107829	Derived	You S, Xie Y, Ji M, Liu C, Zhao Y, Gong C, Hu S, Li Y, Yang Z, Wang B. ER status conversion and subsequent treatment: an assessment of negative ER expression detected by 18F-FES PET in metastatic breast cancer patients with ER-positive primary tumors. Ther Adv Med Oncol. 2023 Dec 15;15:17588359231216093. doi: 10.1177/17588359231216093. eCollection 2023.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases