Hyperpolarized xenon-129 MRI to monitor radiation response and lung toxicity in lung cancer

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

This trial will try inhaled hyperpolarized xenon-129 MRI scans to see if they can detect and predict radiation-related lung side effects in adults receiving radiation for lung cancer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Drugs / interventions: Radiation
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06909201 on ClinicalTrials.gov

What this trial studies

This phase 1 interventional protocol uses inhaled hyperpolarized 129Xe MRI performed before, during, and after external-beam radiation to identify imaging features linked to radiation pneumonitis. Scans will be compared with each patient’s radiation treatment plan and with CT-based ventilation metrics, and healthy controls will provide baseline imaging data. The study also aims to optimize 129Xe MRI acquisition techniques, determine whether imaging changes precede symptoms, and identify lung regions most susceptible to radiation damage. Investigators plan to explore creating alternative radiation plans informed by 129Xe MRI functional maps to potentially reduce toxicity.

Who should consider this trial

Good fit: Adults (≥18) with biopsy-proven lung cancer who are receiving photon- or proton-based external-beam radiotherapy, can undergo MRI, can hold their breath for 10–12 seconds, and will follow up at MD Anderson are ideal candidates.

Not a fit: People who are pregnant, cannot undergo MRI (for example due to incompatible implants), cannot hold their breath for 10–12 seconds, or who are not receiving radiation therapy are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this technique could let doctors spot early lung damage from radiation and help design treatment plans that lower the risk of radiation pneumonitis.

How similar studies have performed: Hyperpolarized 129Xe MRI has shown promise in research for mapping ventilation and gas exchange in other lung diseases, but using it to predict radiation pneumonitis is a novel and largely unproven application.

Eligibility criteria

Inclusion Criteria:

1. Healthy control cohort:

   1. Able to consistently hold breath for 10-12 seconds
   2. No history of any pulmonary disorders (i.e., asthma, COPD, lung cancer, etc.)
   3. Able to undergo MRI examination
   4. At least 18 years of age
2. Lung cancer patient cohort:

   1. Biopsy proven diagnosis of lung cancer
   2. Receiving photon- or proton-based external beam radiotherapy as a part of treatment
   3. Able to undergo MRI examination
   4. Will receive follow-up at University of Texas MD Anderson Cancer Center (UTMDACC)
   5. Able to consistently hold breath for 10-12 seconds
   6. Women and men with child-bearing potential agree to use adequate contraception prior to study entry and during the duration of study participation.
   7. Able to understand and willing to sign a written informed consent document
   8. 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.

Exclusion Criteria:

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

Where this trial is running

Houston, Texas

• The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Joshua Niedzielski — M.D. Anderson Cancer Center
• Study coordinator: Joshua Niedzielski, PHD

Conditions Lung Cancer