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NCT04874558 Clinical Trial

Ultra-low-dose Chest CT for HHT

Hereditary Hemorrhagic Telangiectasia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04874558
Other study ID # 21-000324
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date May 1, 2024

Study information
Verified date June 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 10
Est. completion date May 1, 2024
Est. primary completion date May 1, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Year to 17 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Hereditary Hemorrhagic Telangiectasia
  • Telangiectasia, Hereditary Hemorrhagic
  • Telangiectasis

Intervention

Diagnostic Test:
• Ultra-low dose chest CT
A novel CT technique with a new dose optimization and efficiency technology and automatic kV selection, which greatly reduces the dose of radiation exposure compared to a standard chest CT.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ultra-low dose images PAVM detection Number of images detecting PAVM using the ultra-low dose images (50% or lower compared to the full dose) Baseline
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Completed NCT03572556 - Prospective Descriptive Study of the Angiogenic T Cell Population in Subjects With Hereditary Hemorrhagic Telangiectasia (HHT)
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