Clinical trial NCT04108052: Diagnostic Value of Ultra-low Dose Thoracic Scanner for the Pulmonary Arteriovenous Malformation Detection in HHT Patient
Official title: Diagnostic Value of Ultra-low Dose Thoracic Scanner for the Pulmonary Arteriovenous Malformation Detection in HHT Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telangiectasia, Hereditary Hemorrhagic
Rendu Osler Disease
Keywords: Hereditary Hemorrhagic Telangiectasia (HHT)
diagnosis,
arteriovenous malformation
interventional radiology
pulmonary arteriovenous fistulas
embolization
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patient monitored for a clinically confirmed Rendu-Osler disease and / or confirmed by molecular biology, seen for an initial assessment or for a reassessment of PAVM (after treatment or without treatment)
* Patient who agreed to participate in the study and signed the written informed consent
* Patient affiliated to a social security scheme or similar

Exclusion Criteria:

* Women who are pregnant, nursing (lactating) or at risk of pregnancy (verified by a urine test before performing the scanner)
* Patient who is protected adults under the terms of the law (French Public Health Code).
* Patient who has not or poorly understand French

Primary outcomes:
measure: Comparison of diagnostic performances (specificity and sensitivity) between ultra-low dose and low dose CT scanner
timeFrame: Day one
Secondary outcomes:
measure: the effective radiation dose
timeFrame: at thoracic CT acquisition - day one
measure: the computed tomography dose index (CTDI)
timeFrame: at thoracic CT acquisition - day one
measure: the dose length product (DLP)
timeFrame: at thoracic CT acquisition - day one
measure: the size of afferent artery
timeFrame: At the two re-readings - 3 months
measure: the size of efferent vein
timeFrame: At the two re-readings - 3 months
measure: the number of afferent artery
timeFrame: At the two re-readings - 3 months
measure: the quality of images
timeFrame: At the two re-readings - 3 months
measure: the confidence of the diagnosis
timeFrame: At the two re-readings - 3 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon - Hopital Louis Pradel
Study officials:
References: