Functional Lung Avoidance Radiation Therapy Using Hyperpolarized Xenon-129 MRI

NCT05302817 | Terminated Phase 1 FDA Drug

• 1 other identifier: 849026
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer radiation treatment plans that employ lung functional avoidance methods require 3D maps that differentiate regions of healthy lung function from regions of compromised tissue to deliver sufficient dose to the tumor while preserving as much functioning lung as possible. Hyperpolarized xenon-129 MRI can provide maps of ventilatory function and gas exchange to the bloodstream. Improving treatment plans based on this novel imaging modality could reduce risk or severity of radiation pneumonitis and improve post-treatment quality of life.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

lung cancer; non-small-cell lung cancer; radiation therapy; guided radiation therapy; functional lung avoidance; hyperpolarized xenon; HXe MRI

Outcome Measures

Primary Outcomes (1)

• Number of patients reporting one or more adverse events related to hyperpolarized xenon inhalation in this population.

  Phase 1 will assess safety of inhaling hyperpolarized xenon in this patient population with severely affected lung function.

  One year.

Secondary Outcomes (1)

• Number of patients with radiation therapy related adverse events as assessed by CTCAE v4.0.

  One year.

Study Arms (2)

Standard-of-care Radiation Therapy for lung cancer using HXe MRI for diagnosis.

EXPERIMENTAL

Patients with non-small cell lung cancer scheduled for radiation therapy will be voluntarily enrolled in this study, where they will have their lung ventilation and function imaged with hyperpolarized xenon MRI. The 3D HXe images will be used in determining a functional lung avoidance treatment map. However, for this part of the study, subjects will still follow the standard-of-care radiation treatment plan. At 6-month follow up the subjects will be imaged again with HXe to assess lung ventilation and function post-RT compared to baseline (pre-RT). Additionally, standard-of-care lung testing (DLCO, PFT) and quality-of-life questionnaires will be assessed at several time points during the study.

Combination Product: Hyperpolarized xenon MRI

Guided Radiation Therapy for lung cancer using HXe MRI for functional lung avoidance and diagnosis.

EXPERIMENTAL

Patients with non-small cell lung cancer scheduled for radiation therapy will be voluntarily enrolled in this study. They will have their lung ventilation and function imaged with hyperpolarized xenon MRI. The 3D HXe images will be used in determining a functional lung avoidance treatment map. Patients will follow radiation therapy optimized for functional lung avoidance. At 6-month follow up the subjects will be imaged again with HXe to assess lung ventilation and function post-RT compared to baseline (pre-RT). Additionally, standard-of-care lung testing (DLCO, PFT) and quality-of-life questionnaires will be assessed at several time points during the study.

Combination Product: Hyperpolarized xenon MRI

Interventions

Hyperpolarized xenon MRI COMBINATION_PRODUCT

Patients with non-small cell lung cancer scheduled for radiation therapy willing to take part in this study will undergo hyperpolarized xenon MRI at several time points prior and post RT. Images will be used to determine maps for functional lung avoidance and post-RT changes in the lung function and compared to standard-of-care assessment methods.

Guided Radiation Therapy for lung cancer using HXe MRI for functional lung avoidance and diagnosis.; Standard-of-care Radiation Therapy for lung cancer using HXe MRI for diagnosis.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years with a diagnosis of non-small lung cancer and planned for a definitive course of radiation therapy.
• Preferred patients will have had successful radiation therapy for a prior lung cancer and developed a secondary lung cancer for which are to be treated.
• Other de-nuovo lung cancer patients planned for radiation therapy with lung heterogeneity from natural co-morbidities (e.g., COPD stage 3+).

You may not qualify if:

• Patients less than 18 years old
• Patients known to be pregnant - a positive pregnancy test will be used to respectively exclude pregnant patients,
• Any known contraindication to MRI examination
• Anyone with an implanted metal device
• Inability to provide informed consent
• A language, communication, cognitive or behavioral impairment that might interfere with fully informed participation in the study.
• History of uncompensated organ failure (i.e. organ failure that is not stabilized through medical intervention), which will be assessed by the PI.
• Homelessness or other unstable living situation
• Active drug or alcohol dependence
• Claustrophobia
• Subjects weighting more than 300 pounds.
• Subjects with chest size larger than the bore of MRI machine can accommodate

Sponsors & Collaborators

• Xemed LLC: lead
• University of Pennsylvania: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1: open trial for establishing safety and methodology. Phase 1, Part 1: 10 subjects enrolled for establishing methodology for guiding radiation therapy using HXe MRI. Radiation treatment will follow standard-of-care.

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: March 17, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)