Ignite Creation Date:
2024-05-06 @ 1:43 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04108052
Status:
COMPLETED
Last Update Posted:
2021-10-19
First Post:
2019-09-26
Brief Title:
Diagnostic Value of Ultra-low Dose Thoracic Scanner for the Pulmonary Arteriovenous Malformation Detection in HHT Patient
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Diagnostic Value of Ultra-low Dose Thoracic Scanner for the Pulmonary Arteriovenous Malformation Detection in HHT Patient
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ULD OSLER
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ID-RCB | OTHER | 2019-A02025-52 | None |