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

NCT02478255 | Completed Phase 2 Results

• 2 other identifiers: Pro000598561R01HL105643-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

Radiation induced lung injury; Xenon gas; hyperpolarized

Outcome Measures

Primary Outcomes (1)

• Change in Pulmonary Function, as Measured by Ventilation Defect Percentage (VDP)

  "Ventilation" is defined as the regional 129Xe airspace signal divided by the top 1% of 129Xe airspace signal (representing open-airway ventilation). A "Ventilation Defect" is defined as any region of lung where the Ventilation signal is more than 2 standard deviations below the mean Ventilation signal of healthy volunteer subjects' lungs. "Ventilation Defect Percentage", or VDP, is defined as the volume of a subject's Ventilation Defects divided by the volume of the subject's lung, multiplied by 100%.

  Baseline, following radiation treatment (up to 3 months)

Secondary Outcomes (3)

• Change in Gas Exchange Defect Percentage (EDP) Following RT (Radiation Treatment)

  Baseline, following RT (up to 3 months)

• RBC (Red Blood Cell) to Barrier Ratio Following RT

  Baseline, following RT (up to 3 months)

• Change in High Barrier Uptake Percentage (HBUP) Following RT

  Baseline, following RT (up to 3 months)

Other Outcomes (1)

• Change in Perfusion Defect Percentage (PDP) Following RT

  Baseline, following RT (up to 3 months)

Study Arms (2)

Patients scheduled to undergo Radiation Therapy (RT)

ACTIVE COMPARATOR

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.

Drug: Hyperpolarized 129-Xenon gas; Device: MRI

Healthy volunteers

ACTIVE COMPARATOR

Drug: Hyperpolarized 129-Xenon gas; Device: MRI

Interventions

Hyperpolarized 129-Xenon gas 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.

Also known as: Hyperpolarized 129Xe

Healthy volunteers; Patients scheduled to undergo Radiation Therapy (RT)

MRI DEVICE

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

Healthy volunteers; Patients scheduled to undergo Radiation Therapy (RT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient scheduled to undergo thoracic RT at Duke University to a dose of at least 20 Gy
• Willing and able to give informed consent and adhere to visit/protocol schedules

You may not qualify if:

• Subject is less than 18 years old
• MRI is contraindicated based on responses to MRI Screening questionnaire
• Subject is pregnant or lactating
• Respiratory illness of a bacterial or viral etiology within 30 days of MRI
• Subject has any form of known cardiac arrhythmia
• Subject does not fit into 129Xe vest coil used for MRI
• Subject cannot hold his/her breath for 15 seconds
• Subject deemed unlikely to be able to comply with instructions during imaging
• 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
• \. Subject meets all criteria above but does not have a clinical diagnosis of respiratory disease.

Sponsors & Collaborators

• Bastiaan Driehuys: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27713, United States

Location

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Bastiaan Driehuys, PhD (Professor of Radiology)
• Organization: Duke University

bastiaan.driehuys@duke.edu

919 684-7786

Study Officials

• Joseph Mammarappallil, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Radiology

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 23, 2015
• Study Start: March 21, 2016
• Primary Completion: January 13, 2022
• Study Completion: January 13, 2022
• Last Updated: February 17, 2023
• Results First Posted: February 17, 2023

Record last verified: 2023-01

Locations

US (1)