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NCT03681873 Clinical Trial

Validation of Low Dose CT for Diagnosis of Lung Nodules

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03681873
Other study ID # 2018-6122
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 30, 2018
Est. completion date September 7, 2021

Study information
Verified date August 2022
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 78
Est. completion date September 7, 2021
Est. primary completion date September 2, 2020
Accepts healthy volunteers No
Gender All
Age group 4 Years to 20 Years
Eligibility 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 - Lymphoma

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Extremely Low Dose CT
Patients undergoing a clinically indicated chest CT will also undergo the extremely low dose CT

Locations
Country Name City State
United States Cincinnati Children's Hospital Medical Center Burnet Campus Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic performance of extremely low dose CT Sensitivity At time of imaging
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