This phase II trial evaluates whether a new imaging technique called hyperpolarized xenon 129 (HP 129Xe) magnetic resonance imaging (MRI) is useful for identifying and predicting the development of treatment side effects in lung cancer patients undergoing radiation therapy. Patients undergoing radiation therapy for lung cancer often develop a side effect called pneumonitis, which is inflammation of the lungs. HP 129Xe is a gaseous contrast agent that, when inhaled, is distributed throughout the lungs and can be used with MRI to visualize lung structures. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. HP 129Xe MRI may be useful for identifying or predicting the development of radiation-related side effects in lung cancer patients, and may also help physicians develop radiation treatment plans that spare healthy lung tissue.
Additional locations may be listed on ClinicalTrials.gov for NCT06909201.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Temporarily closed to accrual
Contact: Joshua Scott Niedzielski
Phone: 713-745-8946
PRIMARY OBJECTIVES:
I. 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.
II. 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:
I. Optimize HP 129Xe MRI acquisition techniques.
II. To determine if HP 129Xe MRI can pre-emptively detect radiation pneumonitis prior to symptom presentation.
III. Compare changes in HP 129Xe MRI metrics to computed tomography (CT)-based ventilation metrics over the course of radiation therapy.
IV. To identify pulmonary regions more susceptible to radiation damage.
V. 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.
OUTLINE: Healthy controls are assigned to group I and lung cancer patients are assigned to group II.
GROUP I: Participants receive HP 129Xe via inhalation and undergo MRI once on study.
GROUP II: Patients receive HP 129Xe via inhalation and undergo MRI prior to start of standard of care (SOC) radiation therapy, once during SOC radiation therapy, at the completion of SOC radiation therapy, and once 3-6 months after completion of SOC radiation therapy. Patients also undergo SOC CT while on study.
After completion of study intervention, patients are followed for an additional 6 months (up to 12 months total post-radiation therapy).
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorJoshua Scott Niedzielski
