Comparison of MRI and VQ-SPECT as a Screening Test for Patients With Suspected CTEPH: CHANGE-MRI Study Design and...

Area of Science:

• Cardiovascular Imaging
• Pulmonary Hypertension Diagnostics
• Medical Imaging Technology

Background:

• Chronic thromboembolic pulmonary hypertension (CTEPH) diagnosis requires identifying chronic pulmonary embolism and elevated pulmonary artery pressure.
• Current guidelines mandate VQ-SPECT, exposing patients to ionizing radiation.
• A radiation-free alternative is needed for CTEPH diagnosis.

Purpose of the Study:

• To evaluate functional lung MRI as an equivalent diagnostic tool to VQ-SPECT for CTEPH.
• To assess MRI's performance without intravenous contrast.
• To identify MRI-derived parameters for estimating pulmonary artery pressure and predicting survival.

Main Methods:

• Prospective, multicenter, comparative phase III diagnostic trial (CHANGE-MRI).
• Comparison of functional lung MRI against VQ-SPECT for diagnosing chronic pulmonary embolism in suspected CTEPH.
• Gold standard verification using catheter pulmonary angiography or CT pulmonary angiography.
• Co-primary endpoints assess MRI's diagnostic accuracy in SPECT-positive and SPECT-negative cohorts.

Main Results:

• The CHANGE-MRI trial is designed to provide evidence on the diagnostic performance of functional lung MRI.
• The study will compare MRI to VQ-SPECT, assessing its accuracy in detecting chronic pulmonary embolism.
• Performance of contrast-free MRI and predictive capabilities of MRI-derived parameters will be investigated.

Conclusions:

• Functional lung MRI may offer a safe and effective alternative to VQ-SPECT in CTEPH diagnosis.
• The study aims to inform guideline revisions for CTEPH diagnostic strategies.
• MRI could potentially reduce radiation exposure in patients undergoing CTEPH evaluation.