Ultra-low-dose Chest CT for HHT

Active, not recruiting

• Conditions: Hereditary Hemorrhagic Telangiectasia
• Interventions: Diagnostic Test: Ultra-low dose chest CT

• Registration Number: NCT04874558
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-21
• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-03
• Study First Posted: 2021-05-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low-dose contrast-enhanced chest CT exam	Ultra-low dose chest CT	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.

Primary Outcome Measures

Name	Time	Method
Ultra-low dose images PAVM detection	Baseline	Number of images detecting PAVM using the ultra-low dose images (50% or lower compared to the full dose)

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States