Pulmonary Perfusion by Iodine Subtraction Mapping CT Angiography in Acute Pulmonary Embolism: a Diagnostic Accuracy Study Versus Pulmonary Perfusion SPECT.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Brest
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- The sensitivity of iodine mapping by subtraction technique.
Study Overview
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:
- 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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Perfusion SPECT
Included patients with a diagnosis of acute PE on CTPA and who had a subtraction iodine mapping CT will undergo a SPECT/CT within 24 hours.
Each lung subtraction iodine mapping CT will be interpreted blindly by 3 radiologists. Each of the 20 lung segments will be interpreted as normoperfused or hypoperfused.
Each perfusion SPECT will be interpreted blindly by 3 nuclear medicine physicians. Each of the 20 lung segments will be interpreted as normoperfused or hypoperfused.
Intervention: Pulmonary tomoscintigraphy (Diagnostic Test)
Outcomes
Primary Outcomes
The sensitivity of iodine mapping by subtraction technique.
Time Frame: 24 hours
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 .
Secondary Outcomes
- Concordance CTPA - SPECT(24 hours)
- Pulmonary vascular obstruction index(24 hours)
- Concordance CTPA - iodine substraction(24 hours)
- Interobserver reproductibility(24 hours)
- The specificity of iodine mapping by subtraction technique(24 hours)