Pulmonary Embolism
Conditions
Brief 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.
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.
Interventions
DIAGNOSTIC_TESTCTPA
CTPA will be done according to the usual protocol in the radiology department of the investigator center
DIAGNOSTIC_TESTV/Q PET/CT
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
Sponsors
University Hospital, Brest
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with suspected first episode of acute PE, * Age ≥ 18 years . * Insured patient.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of V/Q PET/CT for PE diagnosis | 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 | Baseline | Proportion of patients with a negative V/Q PET/CT among patients without PE according to the reference standard (CTPA). |
Countries
France
Outcome results
None listed