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

NCT03579849 | Completed DMC

• 1 other identifier: 29BRC18.0083 (PASEP)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The specificity of iodine mapping by subtraction technique

  24 hours

• Pulmonary vascular obstruction index

  24 hours

• Concordance CTPA - iodine substraction

  24 hours

• Concordance CTPA - SPECT

  24 hours

• Interobserver reproductibility

  24 hours

Study Arms (1)

Perfusion SPECT

EXPERIMENTAL

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.

Diagnostic Test: Pulmonary tomoscintigraphy

Interventions

Pulmonary tomoscintigraphy DIAGNOSTIC_TEST

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.

Perfusion SPECT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU Brest

Brest, 29200, France

Location

Related Publications (1)

• Dissaux B, Le Floch PY, Robin P, Bourhis D, Couturaud F, Salaun PY, Nonent M, Le Roux PY. Pulmonary perfusion by iodine subtraction maps CT angiography in acute pulmonary embolism: comparison with pulmonary perfusion SPECT (PASEP trial). Eur Radiol. 2020 Sep;30(9):4857-4864. doi: 10.1007/s00330-020-06836-3. Epub 2020 Apr 11.

  PMID: 32279113 RESULT

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: July 9, 2018
• Study Start: June 25, 2018
• Primary Completion: April 24, 2019
• Study Completion: April 25, 2019
• Last Updated: December 3, 2025

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)