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

September 20, 2024 updated by: Centre Hospitalier Universitaire de Besançon
To assess diagnostic performance of Dual Energy CT fo gallblader gallstone detection.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25030
        • CHU de Besançon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: gallblader ultrasound
Other: gallbladder ultrasound
gallbladder ultrasound

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besançon

Investigators

  • Principal Investigator: Paul CALAME, MD, CHU de Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2023

Primary Completion (Actual)

September 19, 2024

Study Completion (Actual)

September 19, 2024

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

January 27, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

September 20, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/743

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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