Ga68 V/Q PET/CT for Pulmonary Embolism Diagnosis: a Diagnostic Accuracy Study vs CT Pulmonary Angiography

University Hospital, Brest100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Pulmonary Embolism

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHRU de BREST

Brest, France

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: Baseline

Data from ClinicalTrials.gov

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