Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment

NCT ID: NCT02478255

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-21
• Study Completion Date: 2022-01-13

Brief Summary

The purpose of this study is to determine whether magnetic resonance imaging (MRI) using inhaled hyper polarized xenon-129 (129Xe) gas, and conventional contrast can help visualize impaired lung function and detect changes over time in patients receiving treatment as well as those who don't. 129Xe is a special type of xenon gas and when inhaled during MRI may be able to show areas of abnormal thickening of parts of the lungs. These images combined with images taken with injected contrast agents or other special types of MRI such as conventional proton (1H) MRI may provide a better way to look at lung structure and function. The ultimate goal is to predict the degree of radiation-induced lung injury that will develop in a given patient for a given treatment plan. The investigators anticipate that these images will provide more specific information about lung disease than standard lung function tests. The use of 129Xe MRI is investigational. Investigational means that these tests have not yet been approved by the US Food and Drug Administration and are only available in research studies like this one. In addition, standard MRI with contrast is not typically done as standard of care for monitoring changes due to thoracic radiation therapy, therefore, its use in this study is also considered investigational.

Healthy volunteers are being asked to participate in this study because to develop a database of functional images that are representative of healthy lungs.

Conditions

Radiation Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients scheduled to undergo Radiation Therapy (RT)

Patients scheduled to undergo Radiation Therapy (RT) for lung cancer, or other malignancies such as breast cancer or lymphoma that involve significant irradiation of the thoracic cavity.

Group Type: ACTIVE_COMPARATOR

Hyperpolarized 129-Xenon gas

Intervention Type: DRUG

Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.

MRI

Intervention Type: DEVICE

Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.

Healthy volunteers

Group Type: ACTIVE_COMPARATOR

Hyperpolarized 129-Xenon gas

Intervention Type: DRUG

Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.

MRI

Intervention Type: DEVICE

Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.

Interventions

Hyperpolarized 129-Xenon gas

Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.

Intervention Type: DRUG

MRI

Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.

Intervention Type: DEVICE

Other Intervention Names

Hyperpolarized 129Xe

Eligibility Criteria

Inclusion Criteria

1. Patient scheduled to undergo thoracic RT at Duke University to a dose of at least 20 Gy

2. Willing and able to give informed consent and adhere to visit/protocol schedules

Exclusion Criteria

1. Subject is less than 18 years old

2. MRI is contraindicated based on responses to MRI Screening questionnaire

3. Subject is pregnant or lactating

4. Respiratory illness of a bacterial or viral etiology within 30 days of MRI

5. Subject has any form of known cardiac arrhythmia

6. Subject does not fit into 129Xe vest coil used for MRI

7. Subject cannot hold his/her breath for 15 seconds

8. Subject deemed unlikely to be able to comply with instructions during imaging

9. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements

1. Subject meets all criteria above but does not have a clinical diagnosis of respiratory disease.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Bastiaan Driehuys

OTHER

Sponsor Role: lead

Responsible Party

Bastiaan Driehuys

Associate Professor of Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Joseph Mammarappallil, M.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01HL105643-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00059856

Identifier Type: -

Identifier Source: org_study_id