Pulmonary Embolism Clinical Trial
— PASEPOfficial title:
Pulmonary Perfusion by Iodine Subtraction Mapping CT Angiography in Acute Pulmonary Embolism: a Diagnostic Accuracy Study Versus Pulmonary Perfusion SPECT.
Verified date | April 2019 |
Source | University Hospital, Brest |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
- Pulmonary embolism (PE) is a diagnostic and therapeutic challenge. The risk of death of
untreated PE is approximately 25%. On the other hand, anticoagulant treatment is
associated with a haemorrhagic risk (2% of major haemorrhagic accidents per year, of
which 10% are fatal). A diagnostic accuracy is therefore necessary.
- Two approaches are available to diagnose PE:
1. A functional approach, represented by pulmonary ventilation / perfusion
scintigraphy (V / P), which looks for the functional consequences of PE. The main
disadvantage of this approach is that there is a high rate of non-diagnostic
examinations. On the other hand, it allows a mapping of pulmonary perfusion at the
microcapillary scale, and thus allows the quantification of the vascular
obstruction index, which would be an independent risk factor of PE recurrence.
2. A morphological approach, represented by CT pulmonary angiography (CTPA), which
allows the visualisation of the clot itself. This approach is currently the most
used but has some limitations, including a risk of over-diagnosis of pulmonary
embolism and the inability to reliably quantify the index of vascular obstruction.
Lung subtraction iodine mapping CT is a new technique allowing, during the realization of a
CTPA, without additional irradiation, to provide a mapping of the iodine. This mapping of
iodine could potentially be used to evaluate pulmonary perfusion.
It would then be possible to obtain, during a single examination, in addition to the
anatomical information of the thoracic angioscan, information on the pulmonary perfusion and
thus to assess the functional consequences of PE.
No study to date has evaluated the performance of the pulmonary subtraction CT for the
evaluation of pulmonary perfusion in the context of acute pulmonary embolism suspicion.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 25, 2019 |
Est. primary completion date | April 24, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All patients who have been diagnosed with acute pulmonary embolism on the Aquilion One Genesis scan (Toshiba, Medical System, Tokyo, Japan) at the Brest University Hospital, and who have had a mapping of the iodine derived from the subtraction images. Exclusion Criteria: - Tomoscintigraphy not feasible within 24 hours. - Massive pulmonary embolism or with signs of gravity - Pregnant or lactating women - Minor patient - Protected adults - Incapacity / refusal to give consent - Hypersensitivity to pertechnetate (99m Tc) - Hypersensitivity to human albumin |
Country | Name | City | State |
---|---|---|---|
France | CHRU Brest | Brest |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Brest |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The sensitivity of iodine mapping by subtraction technique. | The sensitivity of iodine mapping by subtraction technique for the detection of perfusion defects in pulmonary embolism is evaluated with using pulmonary perfusion tomoscintigraphy as a reference standard . | 24 hours | |
Secondary | The specificity of iodine mapping by subtraction technique | The specificity of iodine mapping by subtraction technique for the detection of perfusional defects in acute pulmonary embolism is determinated with using pulmonary perfusion tomoscintigraphy as reference standard. | 24 hours | |
Secondary | Pulmonary vascular obstruction index | Thé correlation between the pulmonary vascular obstruction index measured by iodine mapping by subtraction technique and that obtained by perfusion tomoscintigraphy is evaluating | 24 hours | |
Secondary | Concordance CTPA - iodine substraction | The concordance between the morphological abnormalities visualized at the thoracic angioscanner (visualization of an endoluminal defect within the pulmonary arterial network) is evaluated. | 24 hours | |
Secondary | Concordance CTPA - SPECT | The concordance between the morphological abnormalities on CTPA (visualization of an endoluminal defect within the pulmonary arterial network) is evaluated. | 24 hours | |
Secondary | Interobserver reproductibility | The interobserver reproducibility of subtraction technique versus pulmonary tomoscintigraphy in reported as normal or abnormal lung perfusion at a segmental level. | 24 hours |
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