Ultra-low-dose Chest CT for HHT

June 2, 2023 updated by: Nadir Demirel, Mayo Clinic

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Nadir Demirel, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

May 1, 2022

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 3, 2021

First Posted (Actual)

May 5, 2021

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-000324

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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