- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05704907
Diagnostic Performance of Dual Energy CT for the Detection of Gallbladder Gallstones (DUAL-GB)
February 13, 2023 updated by: Centre Hospitalier Universitaire de Besancon
To assess diagnostic performance of Dual Energy CT fo gallblader gallstone detection.
Study Overview
Status
Not yet recruiting
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 (Anticipated)
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
-
-
-
Besançon, France, 25030
- CHU de Besancon
-
-
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
Genders Eligible for Study
All
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
|
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.
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 (Anticipated)
February 1, 2023
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
June 1, 2023
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)
February 15, 2023
Last Update Submitted That Met QC Criteria
February 13, 2023
Last Verified
December 1, 2022
More Information
Terms related to this study
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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