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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3672 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Planar V/Q-based strategy
Control arm
Device: Planar V/Q-based strategy
Strategy based on planar pulmonary scintigraphy

Active Comparator: CTPA-based strategy
Control arm
Device: CTPA-based strategy
Strategy based on pulmonary angiography

Experimental: V/Q SPECT-based strategy
Experimental arm
Device: V/Q SPECT-based strategy
Strategy based on pulmonary tomoscintigraphy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Proportion of additionnal tests required in each arm [ Time Frame: 3 months ]
    Proportion of patients for whom additional tests are requested in each arm.

  3. Major bleeding incidence in each arm [ Time Frame: 3 months ]
    Incidence of major bleeding episodes in each arm.

  4. Incidence and cause of death in each arm [ Time Frame: 3 months ]
    Incidence and cause of death in each arm



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients with a clinically suspected PE (defined as an acute onset of new or worsening shortness of breath, chest pain, hemoptysis, presyncope, or syncope) without another obvious apparent cause.
  • High pretest clinical probability of PE or a non-high pretest clinical probability but a positive D-Dimer test.

Exclusion Criteria:

  • Age less than 18 years
  • Patients with already confirmed PE
  • Patients with a clinically suspected high-risk pulmonary embolism (hypotension or shock)
  • Use of therapeutic doses of anticoagulants for more than 48 hours
  • Other indication for long-term use of anticoagulants
  • Contraindication to contrast media (including renal insufficiency with a creatinine clearance lower than 30 ml/min)
  • Life expectancy less than 3 months
  • Unable/unwilling to give informed consent
  • Unlikely to comply with study follow-up
  • Ongoing pregnancy or breastfeeding

Information from the National Library of Medicine

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


Contacts
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Contact: Pierre-Yves Salaun 0298223117 pierre-yves.salaun@chu-brest.fr
Contact: Grégoire Le Gal gregoire.legal@chu-brest.fr

Locations
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France
Hopital Saint Esprit Recruiting
Agen, France
Contact: Albert Trinh-Duc    +33(0)553697093    albert.trinh-duc@wanadoo.fr   
CHU d'ANGERS Recruiting
Angers, France, 49933
Contact: Pierre-Marie ROY    0141353715    pmroy@chu-angers.fr   
CHRU de Brest Recruiting
Brest, France, 29609
Contact: Pierre-Yves Salaun    0298223117    pierre-yves.salaun@chu-brest.fr   
Hôpital des Armées Clermont Tonnerre Not yet recruiting
Brest, France
Contact: Nicolas Paleiron    +33 (0)2 98 43 73 01    nicolas.paleiron@free.fr   
CHU Clermont Ferrand Active, not recruiting
Clermont-Ferrand, France
CHU de Dijon Active, not recruiting
Dijon, France
CH des Pays de Morlaix Recruiting
Morlaix, France
Contact: Roge Christophe    +33 (0)2 98 62 61 60    croge@ch-morlaix.fr   
Hegp - Ap-Hp Recruiting
Paris, France, 75015
Contact: Olivier Sanchez    0156093461    olivier.sanchez@ap-hp.fr   
CHU la Réunion Recruiting
Saint-Denis, France
Contact: Xavier COMBES         
CHU de Saint Etienne Recruiting
Saint-Étienne, France
Contact: Laurent Bertoletti    +33(0)477127770    laurent.bertoletti@gmail.com   
CH Toulon Active, not recruiting
Toulon, France
Switzerland
Geneva University Hospital Recruiting
Genève, Switzerland, 1205
Contact: Marc Righini    +41 (0)22 372 92 94    Marc.Righini@hcuge.ch   
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Study Director: Pierre-Yves Salaun CHRU de Brest

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02983760     History of Changes
Other Study ID Numbers: SPECTACULAR - RB 16.068
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Brest:
Pulmonary embolism
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases