Hereditary Hemorrhagic TelangiectasiaNCT04874558
Ultra-low-dose Chest CT for HHT
An observational study of Hereditary Hemorrhagic Telangiectasia, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Hereditary Hemorrhagic Telangiectasia
- What is being tested?
- Ultra-low dose chest CT
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2021to 7 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients followed by HHT clinic who are ordered a chest CTA.
Who may be able to join
- Ages 1 to 17 years
- Diagnosed with positive HHT causing mutations or based on Curacao criteria
Who cannot join
- Acute respiratory distress
- Unstable cardiovascular status
- Pneumothorax, hemoptysis
- Pulmonary edema
- Pulmonary emboli
- Fractured ribs or other chest trauma
- Recent bronchoscopy
- Lung transplantation
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
- Conditions
- Hereditary Hemorrhagic Telangiectasia
- Being tested
- Ultra-low dose chest CT
- Medical subject headings
- Telangiectasia, Hereditary Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-low dose chest CTDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Ultra-low dose chest CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start21 Apr 2021
- Primary completion31 Dec 2025
- Study completion7 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Hemorrhagic TelangiectasiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadir Demirel, Mayo Clinic
- Investigators
- Nadir Demirel, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874558
- Sponsor's protocol ID
- 21-000324
- Status last verified
- Apr 2026
- First submitted
- 3 May 2021
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Ultra-low-dose Chest CT Technique to Screen for Pulmonary Arteriovenous Malformations in Pediatric Patients With Hereditary Hemorrhagic Teleangiectasia
- ClinicalTrials.gov ID
- NCT04874558
- Acronym / sponsor ID
- 21-000324
- Conditions
- Hereditary Hemorrhagic Telangiectasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 7 Mar 2026 (actual)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-dose contrast-enhanced chest CT exam | – | Diagnostic Test: Ultra-low dose chest CTSubjects 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. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients followed by HHT clinic who are ordered a chest CTA.
Key inclusion criteria (2 listed)
- Ages 1 to 17 years
- Diagnosed with positive HHT causing mutations or based on Curacao criteria
Key exclusion criteria (8 listed)
- Acute respiratory distress
- Unstable cardiovascular status
- Pneumothorax, hemoptysis
- Pulmonary edema
- Pulmonary emboli
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultra-low dose chest CTA 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. | Diagnostic test | Low-dose contrast-enhanced chest CT exam |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadir Demirel, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Hemorrhagic Telangiectasia, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultra-low dose images PAVM detection (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.