Pediatrics Mobile CT

NCT ID: NCT07166926

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-10

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pediatric Abdominal Imaging Pediatric Imaging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Mobile CT for pediatric patients in NICU, CVICU, and PICU

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.

Group Type OTHER

Mobile CT

Intervention Type DEVICE

SOMATOM On.site

Interventions

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Mobile CT

SOMATOM On.site

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Size precludes safe operation of the CT gantry
* Unable to consent and parent/guardian unable to consent.
Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Duke University Hospital

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Joseph Cao, MD

Role: CONTACT

919-684-7288

Melody Torain

Role: CONTACT

919-684-7519

Other Identifiers

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Pro00118586

Identifier Type: -

Identifier Source: org_study_id

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