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Diagnostic Performance of Dual Energy CT for the Detection of Gallbladder Gallstones (DUAL-GB)

Primary Purpose

Gallstone

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
gallbladder ultrasound
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gallstone focused on measuring abdominal and pelvic scan, abdominal Ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Besançon

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

gallblader ultrasound

Arm Description

Outcomes

Primary Outcome Measures

Gallstone detection using Dual Energy CT
Number - size of gallstones

Secondary Outcome Measures

Gallstone detection using reconstruction to conventionnal KeV.
Number - size of gallstones

Full Information

First Posted
January 17, 2023
Last Updated
February 13, 2023
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT05704907
Brief Title
Diagnostic Performance of Dual Energy CT for the Detection of Gallbladder Gallstones
Acronym
DUAL-GB
Official Title
Diagnostic Performance of Dual Energy CT for the Detection of Gallbladder Gallstones
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallstone
Keywords
abdominal and pelvic scan, abdominal Ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
gallblader ultrasound
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
gallbladder ultrasound
Intervention Description
gallbladder ultrasound
Primary Outcome Measure Information:
Title
Gallstone detection using Dual Energy CT
Description
Number - size of gallstones
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Gallstone detection using reconstruction to conventionnal KeV.
Description
Number - size of gallstones
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Astrid Pozet
Phone
+33381218988
Email
promotion-interne@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul CALAME, MD
Organizational Affiliation
CHU de Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Astrid Pozet
Phone
+33381218988
Email
apozet@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Paul Calame, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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