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Clinical Trials/NCT04874558
NCT04874558CompletedNot Applicable

Novel Ultra-low-dose Chest CT Technique to Screen for Pulmonary Arteriovenous Malformations in Pediatric Patients With Hereditary Hemorrhagic Teleangiectasia

Mayo Clinic2 sites in 1 country3 target enrollmentStarted: April 21, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
3
Locations
2
Primary Endpoint
Ultra-low dose images PAVM detection

Study Overview

Brief Summary

This study aims to develop a novel ultra-low dose chest CT technology for use in Hereditary Hemorrhagic Teleangiectasia (HHT) patients and to determine the lowest possible radiation dose that is achievable without sacrificing the diagnostic quality.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
1 Year to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Ages 1 to 17 years
  • Diagnosed with positive HHT causing mutations or based on Curacao criteria

Exclusion Criteria

  • Acute respiratory distress
  • Unstable cardiovascular status
  • Pneumothorax, hemoptysis
  • Pulmonary edema
  • Pulmonary emboli
  • Fractured ribs or other chest trauma
  • Recent bronchoscopy
  • Lung transplantation

Arms & Interventions

Low-dose contrast-enhanced chest CT exam

Subjects will undergo a low-dose contrast-enhanced chest CT exam with coverage from the neck base through the lungs to the upper abdomen on a third-generation dual-source CT scanner as part of their routine clinical visit based on current guidelines.

Intervention: Ultra-low dose chest CT (Diagnostic Test)

Outcomes

Primary Outcomes

Ultra-low dose images PAVM detection

Time Frame: Baseline

Number of images detecting PAVM using the ultra-low dose images (50% or lower compared to the full dose)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nadir Demirel

Principal Investigator

Mayo Clinic

Study Sites (2)

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