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

An observational study of Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Lung Cancer
What is being tested?: HP 129Xe MRI
How many people: 70 participants
Where: 1 siteUnited States
Study dates: 31 Mar 2026to 1 Sep 2030
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: MD Anderson Cancer Center Participants

Who may be able to join

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:

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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
The effects of HP 129Xe MRI on the developing human fetus are unknown. For this reason and because radiotherapy is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure.
Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Additionally, if female partners of male study participants become pregnant during study participation, the treating physician should be informed immediately.
Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Joshua Niedzielski, PHD contact

(713) 745-8946

jsniedzielski@mdanderson.org

United States1 site, 1 recruiting

The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Joshua Niedzielski, PHD, 713-745-8946, jsniedzielski@mdanderson.org
Joshua Niedzielski, PHD
Recruiting

Other trials in United States

About this study

The 129Xe tracer has not been FDA approved. Its use in this study is investigational.

Read the detailed description

Primary Objectives:

To assess the association between imaging features on longitudinal HP 129Xe MRI and the development and severity of radiation pneumonitis resulting from radiation therapy for non-small cell lung cancer.

To determine if HP 129Xe MRI features, in conjunction with a given patient's radiation treatment plan, can predict radiation pneumonitis development and severity.

Secondary Objectives:

Optimize HP 129Xe MRI acquisition techniques.

To determine if HP 129Xe MRI can pre-emptively detect radiation pneumonitis prior to symptom presentation.

Compare changes in HP 129Xe MRI metrics to CT-based ventilation metrics over the course of radiation therapy.

To identify pulmonary regions more susceptible to radiation damage.

To develop alternative radiation treatment plans, based on HP 129Xe MRI features of lung function, that may prevent radiation pneumonitis development and compare to standard-of-care treatment plans.

Conditions: Lung Cancer
Being tested: HP 129Xe MRI
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HP 129Xe MRIDrug
Gas delivery will be from a Tedlar bag

Study groups in NCT06909201
Study group	Role	What they receive
Arm A: High-Risk RP Patients		Not described Receives: Drug: HP 129Xe MRI
Arm B: Low-Risk RP Patients		Not described Receives: Drug: HP 129Xe MRI
Arm C: Healthy Volunteers (Negative Control)		Not described Receives: Drug: HP 129Xe MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Through study completion; an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 20261 Sep 2030

First posted3 Apr 2025
Study start31 Mar 2026
Primary completion1 Sep 2028 (estimated)
Study completion1 Sep 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 70 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06909201
Sponsor's protocol ID: 2024-1200
Other IDs: NCI-2025-02425
Status last verified: Aug 2026
First submitted: 27 Mar 2025
Last updated: 25 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No