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Validation of Low Dose CT for Diagnosis of Lung Nodules

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03681873
Recruitment Status : Active, not recruiting
First Posted : September 24, 2018
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date  ICMJE September 18, 2018
First Posted Date  ICMJE September 24, 2018
Last Update Posted Date February 18, 2021
Actual Study Start Date  ICMJE November 30, 2018
Actual Primary Completion Date September 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2018)
Diagnostic performance of extremely low dose CT [ Time Frame: At time of imaging ]
Sensitivity
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validation of Low Dose CT for Diagnosis of Lung Nodules
Official Title  ICMJE Validation of an Extremely Low Dose Computed Tomography Protocol for Diagnosing Lung Nodules in Children and Young Adults
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Cancer
  • Metastasis to Lung
Intervention  ICMJE Diagnostic Test: Extremely Low Dose CT
Patients undergoing a clinically indicated chest CT will also undergo the extremely low dose CT
Study Arms  ICMJE Experimental: Study Group
Patients will receive both the clinically indicated and extremely low dose exams
Intervention: Diagnostic Test: Extremely Low Dose CT
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 20, 2018)
78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Actual Primary Completion Date September 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03681873
Other Study ID Numbers  ICMJE 2018-6122
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor  ICMJE Children's Hospital Medical Center, Cincinnati
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP