Ga68 V/Q PET/CT for Pulmonary Embolism Diagnosis: a Diagnostic Accuracy Study Vs CT Pulmonary Angiography
- Conditions
- Pulmonary Embolism
- Interventions
- Diagnostic Test: V/Q PET/CTDiagnostic Test: CTPA
- Registration Number
- NCT04179539
- Lead Sponsor
- University Hospital, Brest
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Patient with suspected first episode of acute PE,
- Age ≥ 18 years .
- Insured patient.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention CTPA 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). Intervention V/Q PET/CT 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).
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHRU de BREST
🇫🇷Brest, France