Recruiting

HP 129Xe MRI

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06909201

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

HP 129Xe MRI

Study Details

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

Study ID

NCT06909201

Start date

Mar 31, 2026

Status verified date

Aug, 2026

Completion date

Sep 1, 2030

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Arms

Arm A: High-Risk RP Patients

Arm B: Low-Risk RP Patients

Arm C: Healthy Volunteers (Negative Control)

Interventions

HP 129Xe MRI

Gas delivery will be from a Tedlar bag

Primary outcome measure

  • Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Locations

The University of Texas M. D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Joshua Niedzielski, PHD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-25.