Validation of Low Dose CT for Diagnosis of Lung Nodules

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.

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Key information

Conditions

Cancer Metastasis to Lung Neoplasms

Age range

4 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center Burnet Campus

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extremely Low Dose CT

Diagnostic Test

Patients undergoing a clinically indicated chest CT will also undergo the extremely low dose CT

Primary outcomes

Diagnostic performance of extremely low dose CT

Time frame: At time of imaging

Sensitivity

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2021
First posted: Sep 24, 2018
Registry last updated: Aug 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed