Pulmonary Perfusion by Iodine Subtraction Mapping CT Angiography in Acute Pulmonary Embolism

Pulmonary Embolism Clinical Trial

— PASEP  

Official title:

Pulmonary Perfusion by Iodine Subtraction Mapping CT Angiography in Acute Pulmonary Embolism: a Diagnostic Accuracy Study Versus Pulmonary Perfusion SPECT.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03579849
• Other study ID #: 29BRC18.0083 (PASEP)
• Status: Completed
• Phase: N/A
• Start date: June 25, 2018
• Est. completion date: April 25, 2019

Study information

• Verified date: April 2019
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Diagnostic Test:
• Pulmonary tomoscintigraphy
The included patients will benefit from pulmonary tomoscintigraphy within 24 hours after the diagnosis of pulmonary embolism. Each tomoscintigraphy will be interpreted blindly by 3 nuclear physicians. Each of the 20 lung segments will be interpreted as normoperfused or hypoperfused.

Locations

Country	Name	City	State
France	CHRU Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

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