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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Diagnostic test: V/Q PET/CT; Diagnostic test: CTPA

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Pierre-Yves LE ROUX; Phone Number: +33 0298223327; Email: pierre-yves.leroux@chu-brest.fr

Study Locations

• France
  • Brest, France
    • Recruiting
    • CHRU de Brest
    • Contact: Pierre-Yves LE ROUX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; 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).

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; Diagnostic test: CTPA; CTPA will be done according to the usual protocol in the radiology department of the investigator center

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2019
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: PETEP (29BRC18.0275)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No