NCT03417687

Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Resection

Evaluation of Hyperpolarized 129Xe MRI as Compared to 133Xe Scintigraphy for the Assessment of Pulmonary Function in Patients Being Evaluated for Possible Lung Resection Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Polarean, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study compares the equivalence of hyperpolarized 129Xe MRI as compared to 133Xe scintigraphy for the evaluation of pulmonary function in patients being evaluated for lung resection.

Detailed description

This is a multicenter, randomized, open-label, cross-over Phase 3 study evaluating hyperpolarized 129Xe gas MRI as compared to 133Xe scintigraphy for the evaluation of pulmonary function. This study will enroll subjects being evaluated for possible lung resection surgery (i.e. segmentectomy, lobectomy, or pneumonectomy). Subjects will have both a 129Xe MRI and 133Xe scintigraphy image. The vast differences in technique for obtaining hyperpolarized 129Xe MRI as compared to 133Xe scintigraphy make it impossible to blind study procedures. However, all image interpretation will be performed by personnel blinded to the subject's medical history and all study assessments.

Conditions

• Pulmonary Surgical Procedures

Interventions

Type	Name	Description
DRUG	129Xe MRI	Evaluation of pulmonary function
DRUG	133 Xe scintigraphy	Evaluation of pulmonary function

Timeline

• Start date: 2018-08-17
• Primary completion: 2019-10-31
• Completion: 2020-03-10
• First posted: 2018-01-31
• Last updated: 2022-06-28
• Results posted: 2022-06-28

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study