Using Xe MRI to Guide Radiation Therapy for Lung Cancer

NCT06925295 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 202408283
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to explore using MRI scans with xenon to better image lung function, how lung function changes after radiation therapy, and to guide radiation therapy away from parts of the lung that have good function. This project is foundational to performing additional studies to establish if novel MRI imaging can serve as a guidance tool for lung cancer radiation treatment.

Conditions

Imaging Techniques

Keywords

Lung cancer; Xenon; Imaging

Outcome Measures

Primary Outcomes (1)

• The incidence of PFT evidence of radiation pneumonitis and lung function change on spirometry

  is the incidence of PFT evidence of radiation pneumonitis and lung function change. Change in spirometry will be reported as the mean±SD of these measurements for each treatment study visit, and the mean difference of these measurements from baseline.

  Baseline Visit, periprocedural, 1 month follow up visit, and 6 month follow up visit..

Study Arms (2)

Technical Development Arm

EXPERIMENTAL

Lung cancer patients who will undergo standard-of-care stereotactic body radiation therapy (SBRT).

Drug: Xenon MRI; Diagnostic Test: Pulmonary Function Testing; Other: Quality of Life Questionnaire; Other: Medical Research Council Dyspnea score; Other: St. George's Respiratory Questionnaire; Diagnostic Test: Blood Biomarkers

Implementation Arm

EXPERIMENTAL

Lung cancer patients who will undergo SBRT plans that were functionally adapted to avoid highly functioning lung based on Xe MRI.

Drug: Xenon MRI; Diagnostic Test: Pulmonary Function Testing; Other: Quality of Life Questionnaire; Other: Medical Research Council Dyspnea score; Other: St. George's Respiratory Questionnaire; Diagnostic Test: Blood Biomarkers

Interventions

Medical Research Council Dyspnea score OTHER

modified Medical Research Council Dyspnea score (mMRC Dyspnea)

Implementation Arm; Technical Development Arm

St. George's Respiratory Questionnaire OTHER

St. George's Respiratory Questionnaire (SGRQ)

Implementation Arm; Technical Development Arm

Xenon MRI DRUG

MRI with Xenon used for contrast

Implementation Arm; Technical Development Arm

Quality of Life Questionnaire OTHER

European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30+QLQ-LC29)

Implementation Arm; Technical Development Arm

Blood Biomarkers DIAGNOSTIC_TEST

blood biomarkers of inflammation and injury (e.g. Angiopoetin-2, Interleukin-6, myofibroblast activity, BPD4)

Implementation Arm; Technical Development Arm

Pulmonary Function Testing DIAGNOSTIC_TEST

Pulmonary function testing will include spirometry, lung volumes, DLCO and oscillometry

Implementation Arm; Technical Development Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-80 years
• Willing and able to provide informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.)
• Clinical diagnosis of lung cancer made by a board-certified oncologist with intent to treat with stereotactic body radiation therapy. We will not exclude individuals based on cancer type or severity of disease with the exception of the below criteria

You may not qualify if:

• Subjects presenting with any of the following will not be included in the trial:
• Subject is less than 18 years old or incarcerated
• MRI is contraindicated based on responses to MRI screening questionnaire
• Subject is pregnant or lactating
• Resting oxygen saturation \<90% on supplemental oxygen
• Respiratory illness of bacterial or viral etiology within 30 days of planned treatment
• Subject has history of any known ventricular cardiac arrhythmia
• Subject has history of cardiac arrest within the last year
• Subject has prior history of cancer treatment with radiation therapy to the lung
• Subject has concurrent cancer treatment with agents associated with increased risk of radiation pneumonitis (e.g. immunotherapy, chemotherapy)
• 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

Sponsors & Collaborators

• Sean Fain: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sean Fain, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Bruening

CONTACT

319-789-0806; eric-bruening@uiowa.edu

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: Professor

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 13, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

US (1)