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Completed

NCT Number: NCT04179539

Ga68 V/Q 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de BREST

Brest, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V/Q PET/CT

Diagnostic 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

CTPA

Diagnostic Test

CTPA will be done according to the usual protocol in the radiology department of the investigator center

Primary outcomes

  1. Sensitivity of V/Q PET/CT for PE diagnosis

    Time frame: Baseline

    Proportion of patients with a positive V/Q PET/CT among patients with PE according to the reference standard (CTPA).

  2. Specificity of V/Q PET/CT for PE diagnosis

    Time frame: Baseline

    Proportion of patients with a negative V/Q PET/CT among patients without PE according to the reference standard (CTPA).

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: PETEP

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Nov 27, 2019
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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