Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004723-36 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V/Q PET/CT | Diagnostic 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | Baseline |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de BREST | Brest | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32886302 | Result | 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. |
Not provided
Not provided
All collected data that underlie results in a publication
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
Not provided
Not provided
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| CTPA | Diagnostic Test | CTPA will be done according to the usual protocol in the radiology department of the investigator center |
|
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |