NephrolithiasisNCT03656913
Validation of Low Dose CT for Diagnosis of Urolithiasis
A study testing Extremely low dose CT in people with Nephrolithiasis and Ureterolithiases, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The investigators have developed an extremely low dose renal computed tomography (CT) protocol that on preliminary testing has an effective dose in the range of a single view abdominal radiograph. Read more about this study
- Who is it for?
- Ages 4 to 20 years
- Conditions the study is for
- Nephrolithiasis, Ureterolithiases
- What is being tested?
- Extremely low dose CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2018to 28 Sep 2020
- 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 4 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric and young adult patients (ages 4 to <21 years)
- Known or suspected urolithiasis
- Undergoing clinically indicated CT of the abdomen/pelvis
Who cannot join
- Pregnancy
- Prior enrollment in the same study (no patient will be enrolled more than once)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center Burnet Campus
Cincinnati, Ohio, 45229
About this study
Official title: Validation of an Extremely Low Dose Computed Tomography Protocol for Diagnosing Urolithiasis in Children and Young Adults
The investigators have developed an extremely low dose renal computed tomography (CT) protocol that on preliminary testing has an effective dose in the range of a single view abdominal radiograph. The investigators plan to test this exam in patients with known or suspected urolithiasis undergoing clinically indicated CT.
- Conditions
- Nephrolithiasis, Ureterolithiases
- Being tested
- Extremely low dose CT
- Keywords
- Kidney Stone, Renal, Renal Stone
- Medical subject headings
- Nephrolithiasis, Ureterolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extremely low dose CTDiagnostic test
Patients undergoing clinically indicated CT will also receive the extremely low dose CT
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Patients will receive both the clinically indicated and extremely low dose CT exams Receives: Diagnostic Test: Extremely low dose CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of extremely low dose CT
Sensitivity
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start30 Nov 2018
- Primary completion28 Sep 2020
- Study completion28 Sep 2020
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew T Trout, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656913
- Sponsor's protocol ID
- 2018-5183
- Status last verified
- Feb 2021
- First submitted
- 31 Aug 2018
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data sharing
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Extremely Low Dose Computed Tomography Protocol for Diagnosing Urolithiasis in Children and Young Adults
- ClinicalTrials.gov ID
- NCT03656913
- Acronym / sponsor ID
- 2018-5183
- Conditions
- Nephrolithiasis, Ureterolithiases
- Keywords
- Kidney Stone, Renal, Renal Stone
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 4 Sep 2018 (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.
The investigators have developed an extremely low dose renal computed tomography (CT) protocol that on preliminary testing has an effective dose in the range of a single view abdominal radiograph. The investigators plan to test this exam in patients with known or suspected urolithiasis undergoing clinically indicated CT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Diagnostic Test: Extremely low dose CTPatients will receive both the clinically indicated and extremely low dose CT exams |
Who may qualify
- Ages
- 4 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pediatric and young adult patients (ages 4 to <21 years)
- Known or suspected urolithiasis
- Undergoing clinically indicated CT of the abdomen/pelvis
Key exclusion criteria (2 listed)
- Pregnancy
- Prior enrollment in the same study (no patient will be enrolled more than once)
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 |
|---|---|---|
| Extremely low dose CTPatients undergoing clinically indicated CT will also receive the extremely low dose CT | Diagnostic test | Study Group |
Primary outcome
Diagnostic performance of extremely low dose CT
Time frame: Immediate
Sensitivity
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Individual participant dataSharing planned: No. No data sharing
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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.
Andrew T Trout, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extremely low dose CT in people with Nephrolithiasis and Ureterolithiases, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 2 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 18 Feb 2021. 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 United States. 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: Poor recruitment). 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?
Diagnostic performance of extremely low dose CT (time frame: Immediate). 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 18 Feb 2021.