Pulmonary EmbolismSPECTACULARNCT02983760
Comparison of 3 Diagnostic Strategies of PE: Planar V/Q Scan, CTPA, and V/Q SPECT.
A study testing Planar V/Q-based strategy, CTPA-based strategy and V/Q SPECT-based strategy in people with Pulmonary Embolism, run by University Hospital, Brest at 11 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Planar V/Q-based strategy, CTPA-based strategy and V/Q SPECT-based strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 611 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 10 Apr 2017to 17 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 10Show fewer
- Life expectancy less than 3 months
- Unable/unwilling to give informed consent
- Unlikely to comply with study follow-up
- Ongoing pregnancy or breastfeeding
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
France9 sites
Hopital Saint Esprit
Agen
CHU d'ANGERS
Angers, 49933
CHRU de Brest
Brest, 29609
CHU Clermont Ferrand
Clermont-Ferrand
CH des Pays de Morlaix
Morlaix
Hegp - Ap-Hp
Paris, 75015
CHU la Réunion
Saint-Denis
CHU de Saint Etienne
Saint-Etienne
CH Toulon
Toulon
About this study
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)
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).
Read more
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
- Being tested
- Planar V/Q-based strategy, CTPA-based strategy, V/Q SPECT-based strategy
- Keywords
- Pulmonary embolism
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planar V/Q-based strategyDevice
Strategy based on planar pulmonary scintigraphy
CTPA-based strategyDevice
Strategy based on pulmonary angiography
V/Q SPECT-based strategyDevice
Strategy based on pulmonary tomoscintigraphy
| Study group | Role | What they receive |
|---|---|---|
| Planar V/Q-based strategy | Active comparator | Control arm Receives: Device: Planar V/Q-based strategy |
| CTPA-based strategy | Active comparator | Control arm Receives: Device: CTPA-based strategy |
| V/Q SPECT-based strategy | Experimental | Experimental arm Receives: Device: V/Q SPECT-based strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
Proportion of PE diagnostic in each arm
Proportion of patients deemed to have PE according to the strategy in each arm.
Measured: 3 months
Proportion of additionnal tests required in each arm
Proportion of patients for whom additional tests are requested in each arm.
Measured: 3 months
Major bleeding incidence in each arm
Incidence of major bleeding episodes in each arm.
Measured: 3 months
Incidence and cause of death in each arm
Incidence and cause of death in each arm
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start10 Apr 2017
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
Why it stopped: The enrollment process for patients is difficult.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 611 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Yves Salaun, Study director, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983760
- Sponsor's protocol ID
- SPECTACULAR - RB 16.068
- Acronym
- SPECTACULAR
- Status last verified
- Feb 2025
- First submitted
- 28 Nov 2016
- Last updated
- 5 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38754880
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02983760
- Acronym / sponsor ID
- SPECTACULAR / SPECTACULAR - RB 16.068
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary embolism
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The enrollment process for patients is difficult.
- Enrolment
- 611 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Planar V/Q-based strategy | Active comparator | Device: Planar V/Q-based strategyControl arm |
| CTPA-based strategy | Active comparator | Device: CTPA-based strategyControl arm |
| V/Q SPECT-based strategy | Experimental | Device: V/Q SPECT-based strategyExperimental arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Planar V/Q-based strategyStrategy based on planar pulmonary scintigraphy | Device | Planar V/Q-based strategy |
| CTPA-based strategyStrategy based on pulmonary angiography | Device | CTPA-based strategy |
| V/Q SPECT-based strategyStrategy based on pulmonary tomoscintigraphy | Device | V/Q SPECT-based strategy |
Primary outcome
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.
4 secondary outcomes
Proportion of PE diagnostic in each arm
Time frame: 3 months
Proportion of additionnal tests required in each arm
Time frame: 3 months
Major bleeding incidence in each arm
Time frame: 3 months
Incidence and cause of death in each arm
Time frame: 3 months
Results and safety
The study was stopped early (reason given: The enrollment process for patients is difficult.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Derived from this study: PubMed 38754880Le 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Yves Salaun study director
CHRU de Brest
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Planar V/Q-based strategy, CTPA-based strategy and V/Q SPECT-based strategy in people with Pulmonary Embolism, run by University Hospital, Brest at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, Canada, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The enrollment process for patients is difficult.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thromboembolic events rate in a 3 month follow-up period in patients left untreated after a negative diagnostic strategy. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02983760, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.