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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-02425 | Other Identifier | NCI-CTRP Clinical Registry |
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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.
Primary Objectives:
To 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.
To determine if HP 129Xe MRI features, in conjunction with a given patient's radiation treatment plan, can predict radiation pneumonitis development and severity.
Secondary Objectives:
Optimize HP 129Xe MRI acquisition techniques.
To determine if HP 129Xe MRI can pre-emptively detect radiation pneumonitis prior to symptom presentation.
Compare changes in HP 129Xe MRI metrics to CT-based ventilation metrics over the course of radiation therapy.
To identify pulmonary regions more susceptible to radiation damage.
To 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: High-Risk RP Patients |
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| Arm B: Low-Risk RP Patients |
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| Arm C: Healthy Volunteers (Negative Control) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HP 129Xe MRI | Drug | Gas delivery will be from a Tedlar bag |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Healthy control cohort:
Lung cancer patient cohort:
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:
Exclusion Criteria:
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MD Anderson Cancer Center Participants
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joshua Niedzielski, PHD | Contact | (713) 745-8946 | jsniedzielski@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Joshua Niedzielski | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas M. D. Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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