Hyperpolarized Xenon-129 Magnetic Resonance Imaging in Lung Cancer Patients Receiving Radiation Therapy for Investigating Radiation-response and Toxicity

NCT06909201 | Recruiting FDA Drug

• 2 other identifiers: 2024-1200NCI-2025-02425
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if novel type of imaging scan called HP 129Xe MRI can help doctors identify and predict common side effects of radiation therapy. Rather than contrast-enhanced MRIs, the tracer (129Xe) will be inhaled rather than injected. The 129Xe tracer has not been FDA approved. Its use in this study is investigational.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (3)

Arm A: High-Risk RP Patients

Drug: HP 129Xe MRI

Arm B: Low-Risk RP Patients

Drug: HP 129Xe MRI

Arm C: Healthy Volunteers (Negative Control)

Drug: HP 129Xe MRI

Interventions

HP 129Xe MRI DRUG

Gas delivery will be from a Tedlar bag

Arm A: High-Risk RP Patients; Arm B: Low-Risk RP Patients; Arm C: Healthy Volunteers (Negative Control)

Eligibility Criteria

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

Study Population

MD Anderson Cancer Center Participants

You may qualify if:

• Healthy control cohort:
• Able to consistently hold breath for 10-12 seconds
• No history of any pulmonary disorders (i.e., asthma, COPD, lung cancer, etc.)
• Able to undergo MRI examination
• At least 18 years of age
• Lung cancer patient cohort:
• Biopsy proven diagnosis of lung cancer
• Receiving photon- or proton-based external beam radiotherapy as a part of treatment
• Able to undergo MRI examination
• Will receive follow-up at University of Texas MD Anderson Cancer Center (UTMDACC)
• Able to consistently hold breath for 10-12 seconds
• Women and men with child-bearing potential agree to use adequate contraception prior to study entry and during the duration of study participation.
• Able to understand and willing to sign a written informed consent document
• At least 18 years of age
• Postmenopausal (no menses in greater than or equal to 12 consecutive months).

You may not qualify if:

• Patients unable to follow up at MD Anderson for routine clinical care
• Inability or unwillingness to give informed consent
• Relapsed disease or life expectancy less than 6 months at time of enrollment
• Severe claustrophobia precluding MRI imaging active pulmonary infection
• Pregnant women
• Under 18 years of age

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Joshua Niedzielski

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Niedzielski, PHD

CONTACT

(713) 745-8946; jsniedzielski@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: March 31, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

US (1)