Ultra-low-dose Chest CT for HHT

NCT04874558 | Completed

• 1 other identifier: 21-000324
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Hereditary Hemorrhagic Telangiectasia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Diagnostic Test: Ultra-low dose chest CT

Interventions

Ultra-low dose chest CT DIAGNOSTIC_TEST

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.

Low-dose contrast-enhanced chest CT exam

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients followed by HHT clinic who are ordered a chest CTA.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Telangiectasia, Hereditary Hemorrhagic

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Telangiectasis; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Nadir Demirel, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 5, 2021
• Study Start: April 21, 2021
• Primary Completion: December 31, 2025
• Study Completion: March 7, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)