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Clinical Trials/NCT03681873
NCT03681873
Completed
Not Applicable

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

Children's Hospital Medical Center, Cincinnati1 site in 1 country78 target enrollmentNovember 30, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
78
Locations
1
Primary Endpoint
Diagnostic performance of extremely low dose CT
Status
Completed
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
November 30, 2018
End Date
September 7, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Study Sites (1)

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