[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06909201":3,"trial-entities:NCT06909201":86,"trial-summary:NCT06909201":90},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":35,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":21,"healthy_volunteers":43,"eligibility_criteria":44,"std_ages":54,"locations":57,"central_contacts":75,"overall_officials":78,"references":81,"see_also_links":82},"NCT06909201","2024-1200","Hyperpolarized Xenon-129 Magnetic Resonance Imaging in Lung Cancer Patients Receiving Radiation Therapy for Investigating Radiation-response and Toxicity","RECRUITING","2030-09-01","2026-08","2026-08-25","2026-03-31","M.D. Anderson Cancer Center","OTHER",false,"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.\n\nThe 129Xe tracer has not been FDA approved. Its use in this study is investigational.","Primary Objectives:\n\nTo 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.\n\nTo determine if HP 129Xe MRI features, in conjunction with a given patient's radiation treatment plan, can predict radiation pneumonitis development and severity.\n\nSecondary Objectives:\n\nOptimize HP 129Xe MRI acquisition techniques.\n\nTo determine if HP 129Xe MRI can pre-emptively detect radiation pneumonitis prior to symptom presentation.\n\nCompare changes in HP 129Xe MRI metrics to CT-based ventilation metrics over the course of radiation therapy.\n\nTo identify pulmonary regions more susceptible to radiation damage.\n\nTo 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.",[18],"Lung Cancer",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},70,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31},"DRUG","HP 129Xe MRI","Gas delivery will be from a Tedlar bag",[32,33,34],"Arm A: High-Risk RP Patients","Arm B: Low-Risk RP Patients","Arm C: Healthy Volunteers (Negative Control)",[36],{"measure":37,"description":38,"timeFrame":39},"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","Through study completion; an average of 1 year",[],"ALL","18 Years",true,{"inclusion":45,"exclusion":52,"raw_text":53},[46,47,48,49,50,51],"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\u002FPartner 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.",[],"Inclusion Criteria:\n\n1. Healthy control cohort:\n\n   1. Able to consistently hold breath for 10-12 seconds\n   2. No history of any pulmonary disorders (i.e., asthma, COPD, lung cancer, etc.)\n   3. Able to undergo MRI examination\n   4. At least 18 years of age\n2. Lung cancer patient cohort:\n\n   1. Biopsy proven diagnosis of lung cancer\n   2. Receiving photon- or proton-based external beam radiotherapy as a part of treatment\n   3. Able to undergo MRI examination\n   4. Will receive follow-up at University of Texas MD Anderson Cancer Center (UTMDACC)\n   5. Able to consistently hold breath for 10-12 seconds\n   6. Women and men with child-bearing potential agree to use adequate contraception prior to study entry and during the duration of study participation.\n   7. Able to understand and willing to sign a written informed consent document\n   8. At least 18 years of age\n\nThe 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:\n\n* Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n* History of hysterectomy or bilateral salpingo-oophorectomy.\n* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n* History of bilateral tubal ligation or another surgical sterilization procedure.\n* 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\u002FPartner 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.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Patients unable to follow up at MD Anderson for routine clinical care\n2. Inability or unwillingness to give informed consent\n3. Relapsed disease or life expectancy less than 6 months at time of enrollment\n4. Severe claustrophobia precluding MRI imaging active pulmonary infection\n5. Pregnant women\n6. Under 18 years of age",[55,56],"ADULT","OLDER_ADULT",[58],{"facility":59,"status":7,"city":60,"state":61,"zip":62,"country":63,"contacts":64,"geoPoint":72},"The University of Texas M. D. Anderson Cancer Center","Houston","Texas","77030","United States",[65,70],{"name":66,"role":67,"phone":68,"email":69},"Joshua Niedzielski, PHD","CONTACT","713-745-8946","jsniedzielski@mdanderson.org",{"name":66,"role":71},"PRINCIPAL_INVESTIGATOR",{"lat":73,"lon":74},29.76328,-95.36327,[76],{"name":66,"role":67,"phone":77,"email":69},"(713) 745-8946",[79],{"name":80,"affiliation":12,"role":71},"Joshua Niedzielski",[],[83],{"label":84,"url":85},"MD Anderson Cancer Center Website","http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":87,"biomarkers":89},[88],"Lung Carcinoma",[],{"nct_id":4,"found":43,"summary":91,"prompt_version":101},{"design":92,"status":93,"heading":94,"summary":95,"follow_up":96,"word_count":97,"commitments":98,"compensation":99,"drugs_mentioned":100},"This is an observational study with up to 70 participants. It is not specified if it is randomized or blinded.","completed","Investigating HP 129Xe MRI in Lung Cancer Patients Receiving Radiation Therapy","This research study is looking at a new type of imaging scan called Hyperpolarized Xenon-129 Magnetic Resonance Imaging (HP 129Xe MRI) to see if it can help doctors understand and predict common side effects of radiation therapy in people with lung cancer. Instead of an injection, you would inhale the 129Xe gas for the scan. This study aims to see if HP 129Xe MRI can identify and predict a side effect called radiation pneumonitis (inflammation of the lungs caused by radiation) and if it can detect it before symptoms appear. The 129Xe tracer is investigational and not yet approved by the FDA. We are looking for up to 70 participants, including healthy volunteers and lung cancer patients.","Safety and side effects will be measured throughout the study, which is expected to last an average of 1 year.",117,"Not specified in the trial record.","Not stated in the trial record.",[29],"v2"]