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Validation of Low Dose CT for Diagnosis of Lung Nodules

Primary Purpose

Cancer, Metastasis to Lung

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Extremely Low Dose CT
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cancer

Eligibility Criteria

4 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cincinnati Children's Hospital Medical Center Burnet Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Group

Arm Description

Patients will receive both the clinically indicated and extremely low dose exams

Outcomes

Primary Outcome Measures

Diagnostic performance of extremely low dose CT
Sensitivity

Secondary Outcome Measures

Full Information

First Posted
September 18, 2018
Last Updated
August 12, 2022
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT03681873
Brief Title
Validation of Low Dose CT for Diagnosis of Lung Nodules
Official Title
Validation of an Extremely Low Dose Computed Tomography Protocol for Diagnosing Lung Nodules in Children and Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 30, 2018 (Actual)
Primary Completion Date
September 2, 2020 (Actual)
Study Completion Date
September 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Metastasis to Lung

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
Patients will receive both the clinically indicated and extremely low dose exams
Intervention Type
Diagnostic Test
Intervention Name(s)
Extremely Low Dose CT
Intervention Description
Patients undergoing a clinically indicated chest CT will also undergo the extremely low dose CT
Primary Outcome Measure Information:
Title
Diagnostic performance of extremely low dose CT
Description
Sensitivity
Time Frame
At time of imaging

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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 Lymphoma
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center Burnet Campus
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34232694
Citation
Thapaliya S, Gilligan LA, Brady SL, Anton CG, Crotty EJ, Nasser MP, Geller JI, Pressey JG, Zhang B, Dillman JR, Trout AT. Comparison of 0.3-mSv CT to Standard-Dose CT for Detection of Lung Nodules in Children and Young Adults With Cancer. AJR Am J Roentgenol. 2021 Dec;217(6):1444-1451. doi: 10.2214/AJR.21.26183. Epub 2021 Jul 7.
Results Reference
derived

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Validation of Low Dose CT for Diagnosis of Lung Nodules

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