NCT02983760: SPECTACULAR

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

Terminated NA Last updated 5 February 2025

What this trial tests

NA trial testing Planar V/Q-based strategy in Pulmonary Embolism in 611 participants. Terminated before completion.

Timeline

10 April 2017

Primary endpoint
17 December 2024

17 December 2024

Quick facts

Lead sponsor	University Hospital, Brest
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	611
Start date	10 April 2017
Primary completion	17 December 2024
Estimated completion	17 December 2024
Sites	11 locations across France, Canada, Switzerland

Drugs / interventions tested

• Planar V/Q-based strategy
• CTPA-based strategy
• V/Q SPECT-based strategy

Conditions studied

• Pulmonary Embolism — all drugs for Pulmonary Embolism →

Sponsor

University Hospital, Brest

Who can join

18 and older, any sex, with Pulmonary Embolism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Diagnostic Management of Pregnant Women With Suspected Pulmonary Embolism.
   Robert-Ebadi H, Le Gal G, Righini M. · · 2022 · cited 6× · PMID 35369309 · DOI 10.3389/fcvm.2022.851985
2. 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.
   Le Pennec R, Le Roux PY, Robin P, Couturaud F, et al · · 2024 · cited 3× · PMID 38754880 · DOI 10.1136/bmjopen-2023-075712
3. Diagnosis of Pulmonary Embolism during Pregnancy.
   Robert-Ebadi H, Moumneh T, Le Gal G, Righini M. · · 2022 · cited 3× · PMID 36010225 · DOI 10.3390/diagnostics12081875