Split Dose CTNCT03429712
Patient- and Task-specific Radiation Dose Optimization for Pediatric Abdominopelvic CT Applications
A study testing Dual-source multi-detector computed tomography (DSSE) in people with Split Dose CT, run by Duke University at 1 site in United States.
Trial summary
Radiation dose reduction has been a primary driver of technology development in multi-detector computed tomography (MDCT). The optimization of radiation dose for patient and task specific computed tomography (CT) applications continues to be an ongoing challenge, especially in pediatric patients where the desire to… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Split Dose CT
- What is being tested?
- Dual-source multi-detector computed tomography (DSSE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2018to 12 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- -
Who cannot join
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Radiation dose reduction has been a primary driver of technology development in multi-detector computed tomography (MDCT). The optimization of radiation dose for patient and task specific computed tomography (CT) applications continues to be an ongoing challenge, especially in pediatric patients where the desire to reduce radiation dose to lowest possible levels leads to both positive and negative effects. A novel research tool on the Siemens dual source (Flash® and Force ®) CT scanners allows one to assess multiple tube current levels from a single CT acquisition without incurring additional dose to the patient. Tube current is a primary contributor to radiation dose and image noise, which are inversely related. This is achieved by independently adjusting the current of each tube, while maintaining same kV in each x-ray tube. Moreover, Duke's medical physics team has developed a method based on mathematical expressions that allows the creation of incremental dose levels from the acquired image data sets. This innovative and powerful tool can be used to compare diagnostic accuracy, detectability, and many more relevant clinical features amongst multiple tube current levels with the attainment of a single CT acquisition.
- Conditions
- Split Dose CT
- Being tested
- Dual-source multi-detector computed tomography (DSSE)
- Keywords
- CT Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-source multi-detector computed tomography (DSSE)Device
Dose split technique in a cohort of pediatric patients to determine, without increase in patient radiation dose, the optimal patient-specific and task-specific radiation dose levels for pediatric cardiothoracic and abdominal CT applications.
| Study group | Role | What they receive |
|---|---|---|
| Dose Split CT | Experimental | Not described Receives: Device: Dual-source multi-detector computed tomography (DSSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Noise
Measured: Up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start15 Sep 2018
- Primary completion12 Apr 2019
- Study completion12 Apr 2019
Why it stopped: Terminated due to slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Split Dose CTStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniele Marin, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429712
- Sponsor's protocol ID
- Pro00077173
- Status last verified
- Nov 2019
- First submitted
- 6 Feb 2018
- Last updated
- 27 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient- and Task-specific Radiation Dose Optimization for Pediatric Abdominopelvic CT Applications
- ClinicalTrials.gov ID
- NCT03429712
- Acronym / sponsor ID
- Pro00077173
- Conditions
- Split Dose CT
- Keywords
- CT Scan
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to slow enrollment.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 12 Apr 2019 (actual)
- Study completion
- 12 Apr 2019 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Posted 27 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radiation dose reduction has been a primary driver of technology development in multi-detector computed tomography (MDCT). The optimization of radiation dose for patient and task specific computed tomography (CT) applications continues to be an ongoing challenge, especially in pediatric patients where the desire to reduce radiation dose to lowest possible levels leads to both positive and negative effects. A novel research tool on the Siemens dual source (Flash® and Force ®) CT scanners allows one to assess multiple tube current levels from a single CT acquisition without incurring additional dose to the patient. Tube current is a primary contributor to radiation dose and image noise, which are inversely related. This is achieved by independently adjusting the current of each tube, while maintaining same kV in each x-ray tube. Moreover, Duke's medical physics team has developed a method based on mathematical expressions that allows the creation of incremental dose levels from the acquired image data sets. This innovative and powerful tool can be used to compare diagnostic accuracy, detectability, and many more relevant clinical features amongst multiple tube current levels with the attainment of a single CT acquisition.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Split CT | Experimental | Device: Dual-source multi-detector computed tomography (DSSE) |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- Pregnant
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 |
|---|---|---|
| Dual-source multi-detector computed tomography (DSSE)Dose split technique in a cohort of pediatric patients to determine, without increase in patient radiation dose, the optimal patient-specific and task-specific radiation dose levels for pediatric cardiothoracic and abdominal CT applications. | Device | Dose Split CT |
Primary outcome
Image Noise
Time frame: Up to 5 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Daniele Marin principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-source multi-detector computed tomography (DSSE) in people with Split Dose CT, run by Duke University 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 1 inclusion and 1 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 27 Nov 2019. 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?
Yes. Results are posted in the registry (first posted 27 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Image Noise (time frame: Up to 5 minutes). 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 27 Nov 2019.