Comparison of 3 Diagnostic Strategies of PE: Planar V/Q Scan, CTPA, and V/Q SPECT. (SPECTACULAR)
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|ClinicalTrials.gov Identifier: NCT02983760|
Recruitment Status : Recruiting
First Posted : December 6, 2016
Last Update Posted : October 16, 2018
Pulmonary embolism (PE) remains a diagnostic challenge. False negative testing exposes patient to the risk of potentially fatal recurrence. False positive testing exposes patients to potentially fatal unduly side effects of anticoagulants.
Current diagnostic strategies rely on the sequential use of pretest clinical probability, Ddimer test, and chest imaging. Two chest imaging modalities have been validated for PE diagnostic exclusion: Computed Tomography Pulmonary Angiography (CTPA) and planar V/Q scan. Main limitations of planar V/Q are the high proportion of non-conclusive results, therefore requiring additional testing and more complex diagnostic algorithms. Main limitations of CTPA are its higher radiation dose and contraindications (renal failure).
In a randomized trial that compared strategies based on CTPA and on planar V/Q scan, a 30% increase in the rate of PE diagnoses was found in the arm using CTPA, raising the hypothesis of over-diagnosing and over-treating PE when using CTPA.
V/Q Single Photon Emission CT (SPECT) is a new method of scintigraphic acquisition that has been reported to improve the diagnostic performances of the test, which could reduce the number of non-conclusive tests and allow simplified diagnostic algorithms.
The investigators hypothesize that a strategy based on V/Q SPECT could be an alternative to the two usual approaches responding rightly to the two mains issues and combining the advantages of CTPA (simplified diagnostic approach) and planar V/Q (no overdiagnosis, lower radiation exposure, no contraindication).
Although a recent survey showed that up to 70% of nuclear medicine centers perform SPECT rather than planar imaging for diagnosing PE, a diagnostic management outcome study, in which diagnostic decision would be made on the basis of a standardized algorithm based on the V/Q SPECT is lacking. Such a study needs to be conducted to ensure that the safety of diagnostic exclusion using a V/Q SPECT based strategy is non-inferior to that of previously validated strategies, and to verify that the use of V/Q SPECT does not lead to over-diagnosis.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Embolism||Device: Planar V/Q-based strategy Device: CTPA-based strategy Device: V/Q SPECT-based strategy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3672 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of 3 Diagnostic Strategies of Pulmonary Embolism : Planar Ventilation-perfusion Scintigraphy (Planar V/Q Scan), Computed Tomography Pulmonary Angiography (CTPA), and V/Q Single Photon Emission Computed Tomography (SPECT)|
|Actual Study Start Date :||April 10, 2017|
|Estimated Primary Completion Date :||July 10, 2020|
|Estimated Study Completion Date :||July 10, 2020|
Active Comparator: Planar V/Q-based strategy
Device: Planar V/Q-based strategy
Strategy based on planar pulmonary scintigraphy
Active Comparator: CTPA-based strategy
Device: CTPA-based strategy
Strategy based on pulmonary angiography
Experimental: V/Q SPECT-based strategy
Device: V/Q SPECT-based strategy
Strategy based on pulmonary tomoscintigraphy
- Thromboembolic events rate in a 3 month follow-up period in patients left untreated after a negative diagnostic strategy. [ Time Frame: 3 months ]Rate of symptomatic objectively confirmed thromboembolic events during the 3-month follow-up period in patients left untreated after a negative diagnostic work-up in V/Q SPECT-based strategy in comparison with planar V/Q-based strategy and CTPA-based strategy.
- Proportion of PE diagnostic in each arm [ Time Frame: 3 months ]Proportion of patients deemed to have PE according to the strategy in each arm.
- Proportion of additionnal tests required in each arm [ Time Frame: 3 months ]Proportion of patients for whom additional tests are requested in each arm.
- Major bleeding incidence in each arm [ Time Frame: 3 months ]Incidence of major bleeding episodes in each arm.
- Incidence and cause of death in each arm [ Time Frame: 3 months ]Incidence and cause of death in each arm
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983760
|Contact: Pierre-Yves Salaunfirstname.lastname@example.org|
|Contact: Grégoire Le Galemail@example.com|
|Hopital Saint Esprit||Recruiting|
|Contact: Albert Trinh-Duc +33(0)553697093 firstname.lastname@example.org|
|Angers, France, 49933|
|Contact: Pierre-Marie ROY 0141353715 email@example.com|
|CHRU de Brest||Recruiting|
|Brest, France, 29609|
|Contact: Pierre-Yves Salaun 0298223117 firstname.lastname@example.org|
|Hôpital des Armées Clermont Tonnerre||Not yet recruiting|
|Contact: Nicolas Paleiron +33 (0)2 98 43 73 01 email@example.com|
|CHU Clermont Ferrand||Active, not recruiting|
|CHU de Dijon||Active, not recruiting|
|CH des Pays de Morlaix||Recruiting|
|Contact: Roge Christophe +33 (0)2 98 62 61 60 firstname.lastname@example.org|
|Hegp - Ap-Hp||Recruiting|
|Paris, France, 75015|
|Contact: Olivier Sanchez 0156093461 email@example.com|
|CHU la Réunion||Recruiting|
|Contact: Xavier COMBES|
|CHU de Saint Etienne||Recruiting|
|Contact: Laurent Bertoletti +33(0)477127770 firstname.lastname@example.org|
|CH Toulon||Active, not recruiting|
|Geneva University Hospital||Recruiting|
|Genève, Switzerland, 1205|
|Contact: Marc Righini +41 (0)22 372 92 94 Marc.Righini@hcuge.ch|
|Study Director:||Pierre-Yves Salaun||CHRU de Brest|