Using Xe MRI to Guide Radiation Therapy for Lung Cancer

ConditionImaging Techniques

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-80

SponsorSean Fain

About this trial

The purpose of this research study is to explore using MRI scans with xenon to better image lung function, how lung function changes after radiation therapy, and to guide radiation therapy away from parts of the lung that have good function. This project is foundational to performing additional studies to establish if novel MRI imaging can serve as a guidance tool for lung cancer radiation treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-80 years

Willing and able to provide informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.)

Clinical diagnosis of lung cancer made by a board-certified oncologist with intent to treat with stereotactic body radiation therapy. We will not exclude individuals based on cancer type or severity of disease with the exception of the below criteria

Disqualifiers

Subject is less than 18 years old or incarcerated

MRI is contraindicated based on responses to MRI screening questionnaire

Subject is pregnant or lactating

Resting oxygen saturation <90% on supplemental oxygen

Trial design

Design model

Parallel

Treatments tested in this trial

Xenon MRI
Drug
MRI with Xenon used for contrast
Pulmonary Function Testing
Diagnostic test
Pulmonary function testing will include spirometry, lung volumes, DLCO and oscillometry
Quality of Life Questionnaire
Other intervention
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30+QLQ-LC29)
Medical Research Council Dyspnea score
Other intervention
modified Medical Research Council Dyspnea score (mMRC Dyspnea)
St. George's Respiratory Questionnaire
Other intervention
St. George's Respiratory Questionnaire (SGRQ)
Blood Biomarkers
Diagnostic test
blood biomarkers of inflammation and injury (e.g. Angiopoetin-2, Interleukin-6, myofibroblast activity, BPD4)

Treatment groups

15 Participants

are divided into 2 treatment groups

Group A: Technical Development ArmExperimental treatment 6 interventions

Group B: Implementation ArmExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

The incidence of PFT evidence of radiation pneumonitis and lung function change on spirometry

is the incidence of PFT evidence of radiation pneumonitis and lung function change. Change in spirometry will be reported as the mean±SD of these measurements for each treatment study visit, and the mean difference of these measurements from baseline.

Time frame

Baseline Visit, periprocedural, 1 month follow up visit, and 6 month follow up visit..

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sean Fain

Lead sponsor

University of Iowa

Sponsor institution

Source ClinicalTrials.gov

Apply now