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

Pulmonary Embolism Clinical Trial

— SPECTACULAR  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02983760
• Other study ID #: SPECTACULAR - RB 16.068
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2017
• Est. completion date: July 10, 2022

Study information

• Verified date: July 2021
• Source: University Hospital, Brest
• Contact: Pierre-Yves Salaun
• Phone: 0298223117
• Email: pierre-yves.salaun[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3672
• Est. completion date: July 10, 2022
• Est. primary completion date: July 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Device:
• Planar V/Q-based strategy
Strategy based on planar pulmonary scintigraphy
• CTPA-based strategy
Strategy based on pulmonary angiography
• V/Q SPECT-based strategy
Strategy based on pulmonary tomoscintigraphy

Locations

Country	Name	City	State
France	Hopital Saint Esprit	Agen
France	CHU d'ANGERS	Angers
France	CHRU de Brest	Brest
France	Hôpital des Armées Clermont Tonnerre	Brest
France	CHU Clermont Ferrand	Clermont-Ferrand
France	CHU de Dijon	Dijon
France	CH des Pays de Morlaix	Morlaix
France	Hegp - Ap-Hp	Paris
France	CHU la Réunion	Saint-Denis
France	CHU de Saint Etienne	Saint-Étienne
France	CH Toulon	Toulon
Switzerland	Geneva University Hospital	Genève

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Countries where clinical trial is conducted

France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of PE diagnostic in each arm	Proportion of patients deemed to have PE according to the strategy in each arm.	3 months
Secondary	Proportion of additionnal tests required in each arm	Proportion of patients for whom additional tests are requested in each arm.	3 months
Secondary	Major bleeding incidence in each arm	Incidence of major bleeding episodes in each arm.	3 months
Secondary	Incidence and cause of death in each arm	Incidence and cause of death in each arm	3 months