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

NCT ID: NCT04179539

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-06

Study Completion Date

2024-11-06

Brief Summary

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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

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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.

Conditions

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Pulmonary Embolism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

V/Q PET/CT

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

CTPA

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU de BREST

Brest, , France

Site Status

Countries

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France

Other Identifiers

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PETEP (29BRC18.0275)

Identifier Type: -

Identifier Source: org_study_id