Pediatric Abdominal ImagingNCT07166926
Pediatrics Mobile CT
A study testing Mobile CT in people with Pediatric Abdominal Imaging and Pediatric Imaging, run by Duke University at 1 site in United States.
Trial summary
A special kind of CT scanner that can move around (called a mobile CT) is already approved by the FDA to take pictures of adult and pediatric heads. This study wants to see if the same machine can safely take pictures of the chest and belly (abdomen) in children. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Pediatric Abdominal Imaging, Pediatric Imaging
- What is being tested?
- Mobile CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2025to 23 Jul 2026
- 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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient <5 years of age or meeting size criteria to fit into the CT gantry and field of view (35 cm gantry aperture, 26 cm field of view).
- Patients who would benefit from cross-sectional imaging (CT) of the chest and/or abdomen and pelvis, based on severity and anticipated progression of their disease, as determined by their primary treatment team or recommended by a consultant team.
- Patients who are deemed clinically unsafe to travel based on medical conditions as determined by their primary treatment team.
Who cannot join
- Size precludes safe operation of the CT gantry
- Unable to consent and parent/guardian unable to consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27710
About this study
Official title: Mobile Pediatric Thoracic and Abdominopelvic Computed Tomography (CT)
A special kind of CT scanner that can move around (called a mobile CT) is already approved by the FDA to take pictures of adult and pediatric heads. This study wants to see if the same machine can safely take pictures of the chest and belly (abdomen) in children. This may benefit pediatric patients who may need a CT but are otherwise unable to be safely transported to the radiology department.
- Conditions
- Pediatric Abdominal Imaging, Pediatric Imaging
- Being tested
- Mobile CT
- Keywords
- SOMATOM On.site
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile CTDevice
SOMATOM On.site
| Study group | Role | What they receive |
|---|---|---|
| Mobile CT for pediatric patients in NICU, CVICU, and PICU | Other | Pediatric patients in NICU, CVICU, and PICU who are too ill to transport to the radiology department; could benefit from imaging for diagnosis and care. Advanced imaging modalities like CT can provide critical insights for monitoring pediatric patients with certain conditions. Receives: Device: Mobile CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Images With Good or Acceptable Quality
Image quality will be considered good/acceptable if there is a clinical report. Otherwise it is unacceptable.
Measured: From enrollment to interpretation of the scan (up to approximately 48 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start10 Nov 2025
- Primary completion23 Jul 2026
- Study completion23 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Abdominal ImagingStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166926
- Sponsor's protocol ID
- Pro00118586
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Pediatric Thoracic and Abdominopelvic Computed Tomography (CT)
- ClinicalTrials.gov ID
- NCT07166926
- Acronym / sponsor ID
- Pro00118586
- Conditions
- Pediatric Abdominal Imaging, Pediatric Imaging
- Keywords
- SOMATOM On.site
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 23 Jul 2026 (actual)
- Study completion
- 23 Jul 2026 (actual)
- First posted
- 11 Sep 2025 (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.
A special kind of CT scanner that can move around (called a mobile CT) is already approved by the FDA to take pictures of adult and pediatric heads. This study wants to see if the same machine can safely take pictures of the chest and belly (abdomen) in children. This may benefit pediatric patients who may need a CT but are otherwise unable to be safely transported to the radiology department.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile CT for pediatric patients in NICU, CVICU, and PICU | Other | Device: Mobile CTPediatric patients in NICU, CVICU, and PICU who are too ill to transport to the radiology department; could benefit from imaging for diagnosis and care. Advanced imaging modalities like CT can provide critical insights for monitoring pediatric patients with certain conditions. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patient <5 years of age or meeting size criteria to fit into the CT gantry and field of view (35 cm gantry aperture, 26 cm field of view).
- Patients who would benefit from cross-sectional imaging (CT) of the chest and/or abdomen and pelvis, based on severity and anticipated progression of their disease, as determined by their primary treatment team or recommended by a consultant team.
- Patients who are deemed clinically unsafe to travel based on medical conditions as determined by their primary treatment team.
Key exclusion criteria (2 listed)
- Size precludes safe operation of the CT gantry
- Unable to consent and parent/guardian unable to consent.
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 |
|---|---|---|
| Mobile CTSOMATOM On.site | Device | Mobile CT for pediatric patients in NICU, CVICU, and PICU |
Primary outcome
Number of Images With Good or Acceptable Quality
Time frame: From enrollment to interpretation of the scan (up to approximately 48 hours)
Image quality will be considered good/acceptable if there is a clinical report. Otherwise it is unacceptable.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile CT in people with Pediatric Abdominal Imaging and Pediatric Imaging, 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 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: finished, as of the sponsor's last update on 19 Oct 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Images With Good or Acceptable Quality (time frame: From enrollment to interpretation of the scan (up to approximately 48 hours)). 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 19 Oct 2026.