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

Pulmonary Embolism Clinical Trial

— PETEP  

Official title:

Gallium68 Ventilation/Perfusion PET/CT for Pulmonary Embolism Diagnosis: a Diagnostic Accuracy Study vs CT Pulmonary Angiography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04179539
• Other study ID #: PETEP (29BRC18.0275)
• Status: Recruiting
• Phase: Phase 2
• Start date: December 6, 2019
• Est. completion date: December 2023

Study information

• Verified date: August 2023
• Source: University Hospital, Brest
• Contact: Pierre-Yves LE ROUX
• Phone: 0298223327
• Email: pierre-yves.leroux[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Diagnostic Test:
• V/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
• CTPA
CTPA will be done according to the usual protocol in the radiology department of the investigator center

Locations

Country	Name	City	State
France	CHRU de BREST	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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