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Validation of Low Dose CT for Diagnosis of Lung Nodules

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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

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.

Condition or disease Intervention/treatment Phase
Cancer Metastasis to Lung Diagnostic Test: Extremely Low Dose CT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of an Extremely Low Dose Computed Tomography Protocol for Diagnosing Lung Nodules in Children and Young Adults
Actual Study Start Date : November 30, 2018
Actual Primary Completion Date : September 2, 2020
Estimated Study Completion Date : November 2021

Arm Intervention/treatment
Experimental: Study Group
Patients will receive both the clinically indicated and extremely low dose exams
Diagnostic Test: Extremely Low Dose CT
Patients undergoing a clinically indicated chest CT will also undergo the extremely low dose CT




Primary Outcome Measures :
  1. Diagnostic performance of extremely low dose CT [ Time Frame: At time of imaging ]
    Sensitivity



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Ages Eligible for Study:   4 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03681873


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Burnet Campus
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03681873    
Other Study ID Numbers: 2018-6122
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes