Comparison of 3 Diagnostic Strategies of PE: Planar V/Q Scan, CTPA, and V/Q SPECT.

NCT02983760 | Terminated

• 1 other identifier: SPECTACULAR - RB 16.068
• Study Type: interventional
• Target: 611
• Locations: 3 countries
• Sites: 11

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.

Conditions

Pulmonary Embolism

Keywords

Pulmonary embolism

Outcome Measures

Primary Outcomes (1)

• Thromboembolic events rate in a 3 month follow-up period in patients left untreated after a negative diagnostic strategy.

  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.

  3 months

Secondary Outcomes (4)

• Proportion of PE diagnostic in each arm

  3 months

• Proportion of additionnal tests required in each arm

  3 months

• Major bleeding incidence in each arm

  3 months

• Incidence and cause of death in each arm

  3 months

Study Arms (3)

Planar V/Q-based strategy

ACTIVE COMPARATOR

Control arm

Device: Planar V/Q-based strategy

CTPA-based strategy

ACTIVE COMPARATOR

Control arm

Device: CTPA-based strategy

V/Q SPECT-based strategy

EXPERIMENTAL

Experimental arm

Device: V/Q SPECT-based strategy

Interventions

Planar V/Q-based strategy DEVICE

Strategy based on planar pulmonary scintigraphy

Planar V/Q-based strategy

CTPA-based strategy DEVICE

Strategy based on pulmonary angiography

CTPA-based strategy

V/Q SPECT-based strategy DEVICE

Strategy based on pulmonary tomoscintigraphy

V/Q SPECT-based strategy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (11)

Ottawa

Ottawa, Canada

Location

Hopital Saint Esprit

Agen, France

Location

CHU d'ANGERS

Angers, 49933, France

Location

CHRU de Brest

Brest, 29609, France

Location

CHU Clermont Ferrand

Clermont-Ferrand, France

Location

CH des Pays de Morlaix

Morlaix, France

Location

Hegp - Ap-Hp

Paris, 75015, France

Location

CHU la Réunion

Saint-Denis, France

Location

CHU de Saint Etienne

Saint-Etienne, France

Location

CH Toulon

Toulon, France

Location

Geneva University Hospital

Geneva, 1205, Switzerland

Location

Related Publications (1)

• Le Pennec R, Le Roux PY, Robin P, Couturaud F, Righini M, Le Gal G, Salaun PY. Comparison of three diagnostic strategies for suspicion of pulmonary embolism: planar ventilation-perfusion scan (V/Q), CT pulmonary angiography (CTPA) and single photon emission CT ventilation-perfusion scan (SPECT V/Q): a protocol of a randomised controlled trial. BMJ Open. 2024 May 15;14(5):e075712. doi: 10.1136/bmjopen-2023-075712.

  PMID: 38754880 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

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

Study Officials

• Pierre-Yves Salaun

  CHRU de Brest

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 6, 2016
• Study Start: April 10, 2017
• Primary Completion: December 17, 2024
• Study Completion: December 17, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

CH (1); CA (1); FR (9)