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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: jsniedzielski@mdanderson.org
• Phone: (713) 745-8946

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ePRO in advanced lung cancer: emotional distress, brain metastasis, and symptom burden

  This study tests how patients with advanced lung cancer—some with brain metastases—report emotional distress and symptoms over time using electronic questionnaires.

  Recruiting Tongji Hospital · Hubei, Wuhan · NCT07912190

• Urine VOC Test to Detect Lung Cancer in Never Smokers

  A urine test that looks for volatile compounds is tested to see if it can help detect lung cancer in adults who have never smoked.

  Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania · NCT07871656

• SI-B036 safety test in advanced and metastatic solid tumors

  This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.

  Recruiting at 4 sites Phase 1 SystImmune Inc. · New Haven, Connecticut and 6 other locations · NCT07857616

• Guaraná Supplement for Cancer-Related Fatigue in People Undergoing Treatment

  This study tests whether taking guaraná capsules helps reduce cancer-related fatigue and improve quality of life in adults with breast, lung, colorectal, or gastric cancer who are actively receiving treatment.

  Recruiting Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo · Bogotá, Bogota D.C. · NCT07816263

• ENPP1/cGAS and FAP in Solid Tumors in Vietnamese Patients

  This Vietnam-based study will test ENPP1, cGAS, and FAP expression in archived tumor samples from Vietnamese adults with solid cancers using immunohistochemistry.

  Recruiting at 2 sites Tam Anh Research Institute · Hanoi, Hanoi and 1 other locations · NCT07808164

• Olive oil before lung cancer surgery to see if it lowers chylothorax

  This study tests whether drinking 40 mL of extra-virgin olive oil a few hours before lung cancer surgery can reduce chylothorax after tumor removal.

  Recruiting Fudan University · Shanghai, Xuhui · NCT07807696

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.