Other Clinical Trial - Diagnostic Value of Ultra-low Dose Thoracic Scanner

Status Completed

Clinical Trial Summary

Hereditary hemorrhagic telangiectasia (HHT) is linked to a dysregulation of angiogenesis leading to the formation of arteriovenous malformations (AVM): cutaneo-mucous telangiectasia and visceral shunts. The diagnosis is clinical and based on Curaçao criteria: recurrent epistaxis, cutaneo-mucous telangiectasia, hereditary signs and presence of visceral AVM. Pulmonary AVMs (PAVM) expose patients to many potentially life-threatening complications, such as strokes or brain abscesses due to the right-left shunt created and the lack of filtration barrier of the pulmonary capillary within the AVM. These patients should therefore have regular monitoring throughout their life by a chest CT scanner every 5 to 10 years in the absence of PAVM at the initial scan or more often if PAVMs are present. The management of PAVMs is based on their early detection and embolization in interventional radiology during which is set up within the afferent artery of the PAVM an embolizing agent, the coil. However, the risk of cumulative irradiation exposure from thoracic scanners and repeated thoracic embolizations over time could be reduces by a decrease of X-rays dose. A new thoracic CT imaging protocol validated in the United States in the primary screening of lung cancer, the ultra-low dose protocol, is a CT scanner acquired at an irradiation dose equivalent to that of a frontal chest x-ray and in profile. The dose reduction is of 40 times the usual dose of a chest CT scanner. The lung parenchyma has a high natural contrast on thoracic CT images and there are few adjacent attenuating structures allowing a drastic reduction of dose. However, from this dose, the image quality is degraded with an increase of the image noise. The diagnostic performances have to be confirmed with qualitative and quantitative measurements. Thus, the objective of this study is to compare the sensitivity and the specificity of the current scanner and the ultra-low dose scanner to reduce the exposure to X-rays.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Arteriovenous Malformations
Congenital Abnormalities
Telangiectasia, Hereditary Hemorrhagic
Telangiectasis

Clinical Trial Details

NCT number	NCT04108052
Study type	Interventional
Source	Hospices Civils de Lyon
Contact
Status	Completed
Phase	N/A
Start date	November 28, 2019
Completion date	May 28, 2021

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT00733655` - Study of Histological Samples From Patients With Hereditary Haemorrhagic Telangiectasia
Completed	`NCT00355108` - ATERO : A Randomised Study With Tranexamic Acid in Epistaxis of Rendu Osler Syndrome	Phase 3
Completed	`NCT01507480` - The ELLIPSE Study: A Phase-1 Study Evaluating the Tolerance of Bevacizumab Nasal Spray to Treat Epistaxis in Hereditary Hemorrhagic Telangiectasia	Phase 1
Completed	`NCT03910244` - Pomalidomide for the Treatment of Bleeding in HHT	Phase 2
Recruiting	`NCT04976036` - Efficacy of Nintedanib for Treatment of Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) Patients	Phase 2
Completed	`NCT00684879` - Screening Behavior in Adults With Hereditary Hemorrhagic Telangiectasia
Completed	`NCT00004648` - Studies of Hereditary Hemorrhagic Telangiectasia	N/A
Completed	`NCT00230672` - Investigation of Plasma Proteins in Patients With Hereditary Haemorrhagic Telangiectasia and PAVMs
Completed	`NCT03954782` - Efficacy of Nintedanib Per os as a Treatment for Epistaxis in HHT Disease.	Phase 2
Completed	`NCT02484716` - Efficacy of a Timolol Nasal Spray as a Treatment for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) - (TEMPO)	Phase 2
Recruiting	`NCT00230685` - Case Notes Review on Patients With Hereditary Haemorrhagic Telangiectasia
Terminated	`NCT02204371` - Evaluation of Pazopanib on Bleeding in Subjects With Hereditary Haemorrhagic Telangiectasia	Phase 2
Recruiting	`NCT00230620` - Molecular Studies on Hereditary Haemorrhagic Telangiectasia Families
Recruiting	`NCT02157987` - Treatment of Hereditary Hemorrhagic Telangiectasia of the Nasal Mucosa by Intranasal Bevacizumab : Search for Effective Dose	Phase 1/Phase 2
Completed	`NCT01408030` - North American Study of Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)	Phase 2
Completed	`NCT00230659` - Investigation of Coagulation Parameters in Hereditary Haemorrhagic Telangiectasia
Withdrawn	`NCT00733629` - Study of Endothelial Cells in Patients With Hereditary Haemorrhagic Telangiectasia
Active, not recruiting	`NCT00230633` - Studies of White Blood Cells Derived From HHT Patients
Recruiting	`NCT05933330` - Hereditary Hemorrhagic Telangiectasia and Neurovascular Manifestations, in the Danish HHT Database

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Diagnostic Value of Ultra-low Dose Thoracic Scanner for the Pulmonary Arteriovenous Malformation Detection in HHT Patient — ULD OSLER

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms