GallstoneDUAL-GBNCT05704907
Diagnostic Performance of Dual Energy CT for the Detection of Gallbladder Gallstones
A study testing gallbladder ultrasound in people with Gallstone, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
To assess diagnostic performance of Dual Energy CT fo gallblader gallstone detection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallstone
- What is being tested?
- gallbladder ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jul 2023to 19 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
To assess diagnostic performance of Dual Energy CT fo gallblader gallstone detection.
Read the 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.
- Conditions
- Gallstone
- Being tested
- gallbladder ultrasound
- Keywords
- abdominal and pelvic scan, abdominal Ultrasound
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gallbladder ultrasoundOther
gallbladder ultrasound
| Study group | Role | What they receive |
|---|---|---|
| gallblader ultrasound | Other | Not described Receives: Other: gallbladder ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gallstone detection using Dual Energy CT
Number - size of gallstones
Measured: Day 0
Secondary outcomes (1)
Gallstone detection using reconstruction to conventionnal KeV.
Number - size of gallstones
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start4 Jul 2023
- Primary completion19 Sep 2024
- Study completion19 Sep 2024
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GallstoneStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul CALAME, MD, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704907
- Sponsor's protocol ID
- 2022/743
- Acronym
- DUAL-GB
- Status last verified
- Sep 2024
- First submitted
- 17 Jan 2023
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Dual Energy CT for the Detection of Gallbladder Gallstones
- ClinicalTrials.gov ID
- NCT05704907
- Acronym / sponsor ID
- DUAL-GB / 2022/743
- Conditions
- Gallstone
- Keywords
- abdominal and pelvic scan, abdominal Ultrasound
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gallblader ultrasound | Other | Other: gallbladder ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gallbladder ultrasoundgallbladder ultrasound | Other | gallblader ultrasound |
Primary outcome
Gallstone detection using Dual Energy CT
Time frame: Day 0
Number - size of gallstones
1 secondary outcome
Gallstone detection using reconstruction to conventionnal KeV.
Time frame: Day 0
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul CALAME, MD principal investigator
CHU de Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gallbladder ultrasound in people with Gallstone, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gallstone detection using Dual Energy CT (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.