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

NCT04179539 | Completed DMC

• 2 other identifiers: PETEP (29BRC18.0275)2018-004723-36
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Intervention

EXPERIMENTAL

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; Diagnostic Test: CTPA

Interventions

CTPA DIAGNOSTIC_TEST

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

Intervention

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with suspected first episode of acute PE,
• Age ≥ 18 years .
• Insured patient.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de BREST

Brest, France

Location

Related Publications (1)

• Blanc-Beguin F, Elies P, Robin P, Tripier R, Kervarec N, Lemarie CA, Hennebicq S, Tromeur C, Cogulet V, Salaun PY, Le Roux PY. 68Ga-Labelled Carbon Nanoparticles for Ventilation PET/CT Imaging: Physical Properties Study and Comparison with Technegas(R). Mol Imaging Biol. 2021 Feb;23(1):62-69. doi: 10.1007/s11307-020-01532-6. Epub 2020 Sep 4.

  PMID: 32886302 RESULT

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 27, 2019
• Study Start: December 6, 2019
• Primary Completion: November 6, 2024
• Study Completion: November 6, 2024
• Last Updated: December 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• 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.

Locations

FR (1)