- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03681873
Validation of Low Dose CT for Diagnosis of Lung Nodules
August 12, 2022 updated by: Children's Hospital Medical Center, Cincinnati
Validation of an Extremely Low Dose Computed Tomography Protocol for Diagnosing Lung Nodules in Children and Young Adults
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center Burnet Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study Group
Patients will receive both the clinically indicated and extremely low dose exams
|
Patients undergoing a clinically indicated chest CT will also undergo the extremely low dose CT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic performance of extremely low dose CT
Time Frame: At time of imaging
|
Sensitivity
|
At time of imaging
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2018
Primary Completion (Actual)
September 2, 2020
Study Completion (Actual)
September 7, 2021
Study Registration Dates
First Submitted
September 18, 2018
First Submitted That Met QC Criteria
September 20, 2018
First Posted (Actual)
September 24, 2018
Study Record Updates
Last Update Posted (Actual)
August 15, 2022
Last Update Submitted That Met QC Criteria
August 12, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-6122
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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