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

Plain English Summary

Hyperpolarized Xenon-129 Magnetic Resonance Imaging in Lung Cancer Patients Receiving Radiation Therapy for Investigating Radiation-response and Toxicity is a Phase 1 clinical trial sponsored by M.D. Anderson Cancer Center studying Lung Cancer. This trial tests a new type of MRI scan using inhaled Xenon gas to see if it can help doctors predict side effects from radiation therapy for lung cancer. It is for patients diagnosed with lung cancer who are receiving radiation therapy, and also for healthy volunteers. Participants will undergo a special MRI scan where they inhale a gas. Some patients will also have follow-up scans. Currently, doctors predict radiation side effects based on general patient factors and the radiation dose. This new imaging aims to provide more personalized predictions. The trial aims to enroll 70 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Lung cancer patients receiving radiation therapy who can hold their breath for 10-12 seconds and undergo MRI scans. Healthy volunteers aged 18 or older who can hold their breath for 10-12 seconds and undergo MRI scans, with no history of lung problems. Patients with lung cancer must be able to follow up at MD Anderson Cancer Center. Individuals with severe claustrophobia, active lung infections, or a life expectancy less than 6 months may not be eligible. This trial is studying Lung Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures will show how safe the new imaging scan is and what side effects, if any, occur, helping doctors understand if this new tool can be used reliably in patients. The specific primary outcome measures are: Safety and Adverse Events (AEs) (Through study completion; an average of 1 year). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial matters because it explores a new, non-invasive imaging method that could help doctors better predict and manage radiation therapy side effects for lung cancer patients, filling a gap in pe This research targets Lung Cancer, where improved treatment options are needed.

Investor Insight

This Phase 1 trial investigating an investigational imaging agent for lung cancer patients receiving radiation therapy signals early-stage research into advanced diagnostic tools, with potential for i Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if this investigational imaging scan is appropriate for you and how it might help predict side effects from your radiation therapy. Participation involves undergoing a special MRI scan where you inhale a gas. You will need to be able to hold your breath for about 10-12 seconds. For lung cancer patients, this may involve follow-up scans to monitor changes over time. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 70 participants

Interventions

• DRUG: HP 129Xe MRI — Gas delivery will be from a Tedlar bag

Primary Outcomes

• Safety and Adverse Events (AEs) (Through study completion; an average of 1 year)

Full 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

Trial Locations

• The University of Texas M. D. Anderson Cancer Center, Houston, Texas, United States

Frequently Asked Questions

Related Conditions

• Lung Cancer
• Radiation Therapy
• Medical Imaging
• Magnetic Resonance Imaging (MRI)
• Pulmonary Disorders
• Oncology
• Thoracic Oncology
• Cancer Treatment
• Investigational Drugs
• Clinical Trials

More Lung Cancer Trials

View all Lung Cancer clinical trials