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Clinical Trials/NCT03681873
NCT03681873CompletedNot Applicable

Validation of an Extremely Low Dose Computed Tomography Protocol for Diagnosing Lung Nodules in Children and Young Adults

Children's Hospital Medical Center, Cincinnati2 sites in 1 country78 target enrollmentStarted: November 30, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
78
Locations
2
Primary Endpoint
Diagnostic performance of extremely low dose CT
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The investigators have developed an extremely low dose computed tomography (CT) protocol that on preliminary testing has an effective dose in the range of two chest radiographs. The investigators plan to test this exam in patients with known or suspected cancer undergoing clinically indicated chest CT.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
4 Years to 20 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Pediatric and young adult patients (ages 4 to <21 years)
  • •Known or suspected malignancy other than lymphoma
  • •Undergoing clinically indicated CT of the chest

Exclusion Criteria

  • •Pregnancy identified by routine Department of Radiology verbal screening
  • •Prior enrollment in the same study (no patient will be enrolled more than once)
  • •Inability to provide consent and/or assent

Outcomes

Primary Outcomes

Diagnostic performance of extremely low dose CT

Time Frame: At time of imaging

Sensitivity

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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