Diagnostic Performance of Dual Energy CT for the Detectio... | NCT05704907

Studies
Diagnostic Performance of Dual Energy CT for the Detection of Gallbladder Gallstones

NCT05704907

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Terminated

Last Update Posted

Sep 23, 2024Actual

Enrollment

115Actual

Phase

Not Applicable

Conditions

Gallstone

Interventions

gallbladder ultrasound

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

Sep 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recruitment difficulties

Expanded Access Info

Start Date

Jul 4, 2023Actual

Primary Completion Date

Sep 19, 2024Actual

Completion Date

Sep 19, 2024Actual

First Submitted Date

Jan 17, 2023

First Submission Date that Met QC Criteria

Jan 27, 2023

First Posted Date

Jan 30, 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

Sep 20, 2024

Last Update Posted Date

Sep 23, 2024Actual

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 assess diagnostic performance of Dual Energy CT fo gallblader gallstone detection.

Detailed Description

Detection of gallbladder gallstone using Dual Energy CT compare to gallblader ultrasound (gold standard).

All patients who undergo dual-energy CT scans will undergo abdominal ultrasound for gallstones.

Performance of CT to conventionnal KeV will be compare to low Kev monoenergetic reconstruction, and Effective Z.

Expected duration of inclusion 3-6 months. No follow-up.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

115Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
gallblader ultrasound	Other		Other: gallbladder ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gallbladder ultrasound	Other	gallbladder ultrasound	gallblader ultrasound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gallstone detection using Dual Energy CT	Number - size of gallstones	Day 0

Secondary Outcomes

Measure	Description	Time Frame
Gallstone detection using reconstruction to conventionnal KeV.	Number - size of gallstones	Day 0

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient referred to the radiology department for an abdominal CT for abdominal pain, suspicion of cholangitis, cholecystitis, migration of stones, acute pancreatitis, suspicion of perforated ulcer in the emergency setting.
Non-objection of the subject to participate in the study
Affiliation to a French social security scheme or beneficiary of such a scheme.

Exclusion Criteria:

Cholecystectomy
Legal incapacity or limited legal capacity, legal safeguard
Pregnant women
Subject unlikely to cooperate in the study and/or low cooperation anticipated by the investigator
Subject being in the exclusion period of another study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul CALAME, MD	CHU de Besançon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Besançon		Besançon		25030	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D042882	Gallstones

Ancestor Terms

ID	Term
D002769	Cholelithiasis
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D041761	Cholecystolithiasis

Browse Leaves

Not provided

Browse Branches

Not provided