Feasibility Study of Supine Breast MRI : Comparison With... | NCT03088436

Studies
Feasibility Study of Supine Breast MRI : Comparison With Prone MRI and Comfort Assessment

NCT03088436

Sponsor

Institut de Cancérologie de Lorraine

Status

Completed

Last Update Posted

Mar 23, 2017Actual

Enrollment

47Actual

Phase

Not provided

Conditions

Breast Diseases

Interventions

preoperative prone MRI and supine second-look ultrasound data

Countries

Not provided

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

Mar 2017

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

Jan 1, 2014Actual

Primary Completion Date

Jan 15, 2015Actual

Completion Date

Jan 15, 2015Actual

First Submitted Date

Mar 17, 2017

First Submission Date that Met QC Criteria

Mar 17, 2017

First Posted Date

Mar 23, 2017Actual

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

Mar 17, 2017

Last Update Posted Date

Mar 23, 2017Actual

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

The aim of the present study was to determine the prone-to-supine displacement of breast lesions using preoperative prone MRI and supine second-look ultrasound data

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

47Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
preoperative prone MRI and supine second-look ultrasound data	Device	Patients were examined using a standard clinical MRI protocol in the prone position with both arms placed above the head. Second-look ultrasonographies were performed. Patients were instructed to lie supine, with their hands behind their heads.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
distance to the nipple (mm)	the distance to the nipple for lesion was determined using prone MRI and supine ultrasound	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The inclusion criteria were being a woman with breast lesions whose assessment involved breast MRI and ultrasound at our institution. There were no exclusion criteria.

Exclusion Criteria:

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

Patients records were extracted from the electronic health record system of Institut de Cancérologie de Lorraine

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D001941	Breast Diseases

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided