How Long Must the MRI Follow-up Last to Safely Identify M... | NCT04489550

Studies
How Long Must the MRI Follow-up Last to Safely Identify Middle Ear Residual Cholesteatoma

NCT04489550

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Jul 29, 2020Actual

Enrollment

17Actual

Phase

Not provided

Conditions

Middle Ear Cholesteatoma

Interventions

Not provided

Countries

France

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

Jul 2020

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, 2013Actual

Primary Completion Date

Dec 1, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Jul 23, 2020

First Submission Date that Met QC Criteria

Jul 27, 2020

First Posted Date

Jul 28, 2020Actual

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

Jul 28, 2020

Last Update Posted Date

Jul 29, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Previous studies demonstrated the high diagnostic value of non-echoplanar diffusion weighted magnetic resonance imaging (non-EP DWI) for residual cholesteatoma. However, limited data are available regarding a suitable length of imaging follow-up. The present study aimed to determine the optimal duration of non-EP DWI follow-up for residual cholesteatoma

Detailed Description

A retrospective, monocentric study was performed between 2013 and 2019 and included all patients regularly followed-up after canal wall-up tympanoplasty with at least two non-EP DWI performed on the same 1.5T MRI scanner. MR images were reviewed independently by two radiologists. Sensitivity and specificity values were calculated as a function of time after the surgery. Receiver operating characteristics (ROC) curves were analyzed to determine the optimal follow-up duration.

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

17Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MRI sensitivity and specificity values as a function of the duration of the follow-up	MRI sensitivity and specificity values as a function of the duration of the follow-up. Since no official recommendations are available in the literature, the decision regarding the number of MRIs and the time lapse between any two was left to the discretion of the surgeon	1 day

Secondary Outcomes

Measure	Description	Time Frame
Receiver operating characteristics (ROC) curves	the receiver operating characteristics (ROC) curves	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

- patients regularly followed-up for middle ear cholesteatoma, who underwent two or more non-EP DWI performed on the same 1.5 Tesla MRI scanner

Exclusion criteria:

- congenital cholesteatomas, tympanoplasty with canal wall-down technique, or suspicion of residual cholesteatoma on the first MRI follow-up

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with history of middle-ear cholesteatoma, who underwent canal wall-up tympanoplasty and are therefore at risk of residual cholesteatoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frederic Venail, MD, PhD	University Hospital, Montpellier	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018424	Cholesteatoma, Middle Ear

Ancestor Terms

ID	Term
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D002781	Cholesteatoma
D007642	Keratosis

Browse Leaves

Not provided

Browse Branches

Not provided