Pulmonary EmbolismPETEPNCT04179539
Ga68 V/Q PET/CT for Pulmonary Embolism Diagnosis: a Diagnostic Accuracy Study vs CT Pulmonary Angiography
A study testing V/Q PET/CT and CTPA in people with Pulmonary Embolism, run by University Hospital, Brest at 1 site in France.
Trial summary
This study evaluates the diagnostic accuracy (sensitivity, specificity) of V/Q PET/CT for the diagnosis of pulmonary embolism (PE), using CT pulmonary angiography as a reference standard. 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?
- V/Q PET/CT and CTPA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 6 Dec 2019to 6 Nov 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
- Patient with suspected first episode of acute PE,
- Age ≥ 18 years .
- Insured patient.
Who cannot join
- Patients with a clinically suspected massive PE.
- Contraindication to contrast media (including renal insufficiency with creatinine clearance < 30 ml/min).
- Inability to perform CTPA and V/Q PET/CT within 24 hours.
- History of deep vein thrombosis or PE
- Unable/unwilling to give informed consent.
- Pregnancy / breast-feeding.
- Patient under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gallium68 Ventilation/Perfusion PET/CT for Pulmonary Embolism Diagnosis: a Diagnostic Accuracy Study vs CT Pulmonary Angiography
This study evaluates the diagnostic accuracy (sensitivity, specificity) of V/Q PET/CT for the diagnosis of pulmonary embolism (PE), using CT pulmonary angiography as a reference standard.
Read the detailed description
V/Q PET/CT imaging is now possible by substituting 99mTc with 68Ga, a positron-emitting radionuclide, using the same carrier molecules as conventional V/Q imaging. Ventilation imaging can be performed with 68Ga-carbon nanoparticles using the same synthesis device as Technegas. Perfusion imaging can be performed with 68Ga-macroaggregated albumin (68Ga-MAA).Technical advantages of PET compared to SPECT include higher sensitivity, higher spatial and temporal resolution and superior quantitative capability. This offers the opportunity to improve the accuracy of V/Q imaging in patients with suspected PE, while decreasing the acquisition time.
The aim is to perform a formal diagnostic accuracy study of V/Q PET/CT for PE, using CTPA as a reference standard.
Patients with suspected acute PE undergo CTPA and V/Q PET/CT imaging within 24 hours.
V/Q PET/CT images are not used for patients management.
After completion of inclusion, central readings of scans will be conducted independently.
- Conditions
- Pulmonary Embolism
- Being tested
- V/Q PET/CT, CTPA
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V/Q PET/CTDiagnostic test
Ventilation images are acquired after inhalation of Galligas prepared using a Technegas generator (Cyclopharm, Sydney, Australia). The patients is placed in a supine position and inhaled Galligas using the standard ventilation technique. Ventilation images are then acquired. Without the patient moving, 68Ga-MAA are then injected. Perfusion PET images are then acquired
CTPADiagnostic test
CTPA will be done according to the usual protocol in the radiology department of the investigator center
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients with suspected acute PE undergo CTPA and V/Q PET/CT imaging within 24 hours. V/Q PET/CT images are not used for patients management.
After completion of inclusion, central readings will be independently conducted:
* CTPA will be interpreted by two radiologists, blinded to the results of any clinical information or imaging test results. The results of this interpretation will be used as a reference standard.
* V/Q PET/CT will be interpreted by two independant nuclear medicine physicians, blinded to the results of any clinical information or imaging test results (including the reference standard). Receives: Diagnostic Test: V/Q PET/CT; Diagnostic Test: CTPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of V/Q PET/CT for PE diagnosis
Proportion of patients with a positive V/Q PET/CT among patients with PE according to the reference standard (CTPA).
Measured: Baseline
Specificity of V/Q PET/CT for PE diagnosis
Proportion of patients with a negative V/Q PET/CT among patients without PE according to the reference standard (CTPA).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start6 Dec 2019
- Primary completion6 Nov 2024
- Study completion6 Nov 2024
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179539
- Sponsor's protocol ID
- PETEP (29BRC18.0275)
- Other IDs
- 2018-004723-36, 2018
- Acronym
- PETEP
- Status last verified
- Dec 2024
- First submitted
- 12 Nov 2019
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
Blanc-Beguin F, Elies P, Robin P, Tripier R, Kervarec N, Lemarie CA, Hennebicq S, Tromeur C, Cogulet V, Salaun PY, Le Roux PY. 68Ga-Labelled Carbon Nanoparticles for Ventilation PET/CT Imaging: Physical Properties Study and Comparison with Technegas(R). Mol Imaging Biol. 2021 Feb;23(1):62-69. doi: 10.1007/s11307-020-01532-6. Epub 2020 Sep 4.
PubMed 32886302
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gallium68 Ventilation/Perfusion PET/CT for Pulmonary Embolism Diagnosis: a Diagnostic Accuracy Study vs CT Pulmonary Angiography
- ClinicalTrials.gov ID
- NCT04179539
- Acronym / sponsor ID
- PETEP / PETEP (29BRC18.0275)
- Conditions
- Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 27 Nov 2019 (actual)
- 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.
This study evaluates the diagnostic accuracy (sensitivity, specificity) of V/Q PET/CT for the diagnosis of pulmonary embolism (PE), using CT pulmonary angiography as a reference standard.
Detailed description
V/Q PET/CT imaging is now possible by substituting 99mTc with 68Ga, a positron-emitting radionuclide, using the same carrier molecules as conventional V/Q imaging. Ventilation imaging can be performed with 68Ga-carbon nanoparticles using the same synthesis device as Technegas. Perfusion imaging can be performed with 68Ga-macroaggregated albumin (68Ga-MAA).Technical advantages of PET compared to SPECT include higher sensitivity, higher spatial and temporal resolution and superior quantitative capability. This offers the opportunity to improve the accuracy of V/Q imaging in patients with suspected PE, while decreasing the acquisition time.
The aim is to perform a formal diagnostic accuracy study of V/Q PET/CT for PE, using CTPA as a reference standard.
Patients with suspected acute PE undergo CTPA and V/Q PET/CT imaging within 24 hours.
V/Q PET/CT images are not used for patients management.
After completion of inclusion, central readings of scans will be conducted independently.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: V/Q PET/CT, Diagnostic Test: CTPAPatients with suspected acute PE undergo CTPA and V/Q PET/CT imaging within 24 hours. V/Q PET/CT images are not used for patients management. After completion of inclusion, central readings will be independently conducted: * CTPA will be interpreted by two radiologists, blinded to the results of any clinical information or imaging test results. The results of this interpretation will be used as a reference standard. * V/Q PET/CT will be interpreted by two independant nuclear medicine physicians, blinded to the results of any clinical information or imaging test results (including the reference standard). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with suspected first episode of acute PE,
- Age ≥ 18 years .
- Insured patient.
Key exclusion criteria (7 listed)
- Patients with a clinically suspected massive PE.
- Contraindication to contrast media (including renal insufficiency with creatinine clearance < 30 ml/min).
- Inability to perform CTPA and V/Q PET/CT within 24 hours.
- History of deep vein thrombosis or PE
- Unable/unwilling to give informed consent.
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 |
|---|---|---|
| V/Q PET/CTVentilation images are acquired after inhalation of Galligas prepared using a Technegas generator (Cyclopharm, Sydney, Australia). The patients is placed in a supine position and inhaled Galligas using the standard ventilation technique. Ventilation images are then acquired. Without the patient moving, 68Ga-MAA are then injected. Perfusion PET images are then acquired | Diagnostic test | Intervention |
| CTPACTPA will be done according to the usual protocol in the radiology department of the investigator center | Diagnostic test | Intervention |
Primary outcome
Sensitivity of V/Q PET/CT for PE diagnosis
Time frame: Baseline
Proportion of patients with a positive V/Q PET/CT among patients with PE according to the reference standard (CTPA).
Specificity of V/Q PET/CT for PE diagnosis
Time frame: Baseline
Proportion of patients with a negative V/Q PET/CT among patients without PE according to the reference standard (CTPA).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Results publication: PubMed 32886302Blanc-Beguin F, Elies P, Robin P, Tripier R, Kervarec N, Lemarie CA, Hennebicq S, Tromeur C, Cogulet V, Salaun PY, Le Roux PY. 68Ga-Labelled Carbon Nanoparticles for Ventilation PET/CT Imaging: Physical Properties Study and Comparison with Technegas(R). Mol Imaging Biol. 2021 Feb;23(1):62-69. doi: 10.1007/s11307-020-01532-6. Epub 2020 Sep 4.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V/Q PET/CT and CTPA in people with Pulmonary Embolism, run by University Hospital, Brest at 1 site in France.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity of V/Q PET/CT for PE diagnosis (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT04179539, 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 3 Dec 2025.