In Vivo Depiction Of Bone Vascularization With UHR-CT CT... | NCT05628792

Studies
In Vivo Depiction Of Bone Vascularization With UHR-CT CT And Deep Learning Algorithm Reconstruction: A Preliminary Study

NCT05628792

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Nov 29, 2022Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Bone Vascular Tumor

Interventions

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

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2022Estimated

Primary Completion Date

Jan 31, 2023Estimated

Completion Date

Mar 31, 2023Estimated

First Submitted Date

Oct 28, 2022

First Submission Date that Met QC Criteria

Nov 23, 2022

First Posted Date

Nov 29, 2022Actual

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

Nov 23, 2022

Last Update Posted Date

Nov 29, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

GILLET Romain, MD, MSK Radiologist, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

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

To evaluate the image quality and ability to depict in vivo bone vascularization with an ultra-high-resolution computed tomography (UHR-CT) scanner using a deep learning reconstruction (DLR) and hybrid iterative reconstruction (HIR) algorithms, compared to simulated conventional CT, using osteoid osteoma (OO) as a model.

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

20Estimated

Name	Type	Description	Arm Group Labels	Other Names
CT	Diagnostic Test	Ultra High Resolution CT scan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of cortical vessels	Number	Retrospective review of all ultra high resolution CT of the precedent 2 years
Number of nidus vessels	Number	Retrospective review of all ultra high resolution CT of the precedent 2 years

Secondary Outcomes

Measure	Description	Time Frame
Confidence Score	1 (weak) to 5 (strong)	Retrospective review of all ultra high resolution CT of the precedent 2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Proven osteoid osteoma
Ultra High Resolution CT

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

retrospective inclusion of all histologically proven Osteoid Osteoma referred to our department for CT imaging

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Romain GILLET, MD	Contact	0680987216		romain_gillet3@hotmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010017	Osteoma, Osteoid

Ancestor Terms

ID	Term
D010016	Osteoma
D018213	Neoplasms, Bone Tissue
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue

Browse Leaves

Not provided

Browse Branches

Not provided