Validation of Low Dose CT for Diagnosis of Lung Nodules

Not Applicable

Completed

• Conditions: Cancer; Metastasis to Lung
• Interventions: Diagnostic Test: Extremely Low Dose CT

• Registration Number: NCT03681873
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-09-20
• Study First Posted: 2018-09-24
• Study Start: 2018-11-30
• Primary Completion: 2020-09-02
• Study Completion: 2021-09-07
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-12
• Last Update Posted: 2022-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group	Extremely Low Dose CT	Patients will receive both the clinically indicated and extremely low dose exams

Primary Outcome Measures

Name	Time	Method
Diagnostic performance of extremely low dose CT	At time of imaging	Sensitivity

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center Burnet Campus; 🇺🇸 Cincinnati, Ohio, United States