Recruiting
Phase 2

MRI with Xenon

Sponsor:

Sean Fain

Code:

NCT06925295

Conditions

Imaging Techniques

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Xenon MRI

Pulmonary Function Testing

Quality of Life Questionnaire

Medical Research Council Dyspnea score

St. George's Respiratory Questionnaire

Study Details

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

Study ID

NCT06925295

Start date

Aug 30, 2025

Status verified date

Dec, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial

1. Aged 18-80 years
2. Willing and able to provide informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.)
3. 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

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the trial:

1. Subject is less than 18 years old or incarcerated
2. MRI is contraindicated based on responses to MRI screening questionnaire
3. Subject is pregnant or lactating
4. Resting oxygen saturation <90% on supplemental oxygen
5. Respiratory illness of bacterial or viral etiology within 30 days of planned treatment
6. Subject has history of any known ventricular cardiac arrhythmia
7. Subject has history of cardiac arrest within the last year
8. Subject has prior history of cancer treatment with radiation therapy to the lung
9. Subject has concurrent cancer treatment with agents associated with increased risk of radiation pneumonitis (e.g. immunotherapy, chemotherapy)
10. Subject does not fit into 129Xe vest coil used for MRI
11. Subject cannot hold his/her breath for 15 seconds
12. Subject deemed unlikely to be able to comply with instructions during imaging
13. 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

Study Design

Enrollment

15 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Technical Development Arm

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

experimental: Implementation Arm

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

Interventions

Xenon MRI

MRI with Xenon used for contrast

Pulmonary Function Testing

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

Quality of Life Questionnaire

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

Medical Research Council Dyspnea score

modified Medical Research Council Dyspnea score (mMRC Dyspnea)

St. George's Respiratory Questionnaire

St. George's Respiratory Questionnaire (SGRQ)

Blood Biomarkers

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

Primary outcome measure

  • The incidence of PFT evidence of radiation pneumonitis and lung function change on spirometry [ Time Frame: Baseline Visit, periprocedural, 1 month follow up visit, and 6 month follow up visit.. ]

Central Contacts and Locations

Central contacts

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Principal Investigator:

Sean Fain, PhD

More Information

Sponsor

Sean Fain

Last update posted

Jan 2, 2026

Last verified

Dec, 2025

Keywords

  • Lung cancer
  • Xenon
  • Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sean Fain on 2026-01-02.