Clinical trial NCT03579849: Pulmonary Perfusion by Iodine Subtraction Mapping CT Angiography in Acute Pulmonary Embolism
Official title: Pulmonary Perfusion by Iodine Subtraction Mapping CT Angiography in Acute Pulmonary Embolism: a Diagnostic Accuracy Study Versus Pulmonary Perfusion SPECT.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 30
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: * 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.


Eligibility criteria: 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

Primary outcomes:
measure: The sensitivity of iodine mapping by subtraction technique.
timeFrame: 24 hours
Secondary outcomes:
measure: The specificity of iodine mapping by subtraction technique
timeFrame: 24 hours
measure: Pulmonary vascular obstruction index
timeFrame: 24 hours
measure: Concordance CTPA - iodine substraction
timeFrame: 24 hours
measure: Concordance CTPA - SPECT
timeFrame: 24 hours
measure: Interobserver reproductibility
timeFrame: 24 hours
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
Study officials:
References: