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Pulmonary Perfusion by Iodine Subtraction Mapping CT Angiography in Acute Pulmonary Embolism (PASEP)

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pulmonary tomoscintigraphy
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU Brest

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Perfusion SPECT

Arm Description

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.

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

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.
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
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.
Concordance CTPA - SPECT
The concordance between the morphological abnormalities on CTPA (visualization of an endoluminal defect within the pulmonary arterial network) is evaluated.
Interobserver reproductibility
The interobserver reproducibility of subtraction technique versus pulmonary tomoscintigraphy in reported as normal or abnormal lung perfusion at a segmental level.

Full Information

First Posted
June 11, 2018
Last Updated
April 26, 2019
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT03579849
Brief Title
Pulmonary Perfusion by Iodine Subtraction Mapping CT Angiography in Acute Pulmonary Embolism
Acronym
PASEP
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 25, 2018 (Actual)
Primary Completion Date
April 24, 2019 (Actual)
Study Completion Date
April 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perfusion SPECT
Arm Type
Experimental
Arm Description
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 Type
Diagnostic Test
Intervention Name(s)
Pulmonary tomoscintigraphy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The sensitivity of iodine mapping by subtraction technique.
Description
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 .
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
The specificity of iodine mapping by subtraction technique
Description
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.
Time Frame
24 hours
Title
Pulmonary vascular obstruction index
Description
Thé correlation between the pulmonary vascular obstruction index measured by iodine mapping by subtraction technique and that obtained by perfusion tomoscintigraphy is evaluating
Time Frame
24 hours
Title
Concordance CTPA - iodine substraction
Description
The concordance between the morphological abnormalities visualized at the thoracic angioscanner (visualization of an endoluminal defect within the pulmonary arterial network) is evaluated.
Time Frame
24 hours
Title
Concordance CTPA - SPECT
Description
The concordance between the morphological abnormalities on CTPA (visualization of an endoluminal defect within the pulmonary arterial network) is evaluated.
Time Frame
24 hours
Title
Interobserver reproductibility
Description
The interobserver reproducibility of subtraction technique versus pulmonary tomoscintigraphy in reported as normal or abnormal lung perfusion at a segmental level.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHRU Brest
City
Brest
ZIP/Postal Code
29200
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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