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129Xe MRI for Interstitial Lung Disease
Phase 2
Recruiting
Led By Joseph Mammarappallil, MD
Research Sponsored by Bastiaan Driehuys
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial is testing a new way to detect disease activity in interstitial lung diseases using MRI.
Who is the study for?
This trial is for adults over 18 with Interstitial Lung Disease diagnosed by a specialist. Participants must be able to consent and follow the study plan. It's not for those with low oxygen levels, recent respiratory infections, MRI contraindications, pregnant or breastfeeding women, or individuals unable to hold their breath for 15 seconds.Check my eligibility
What is being tested?
The study aims to perfect a noninvasive lung imaging technique using Hyperpolarized 129Xe gas exchange MRI. This method could help visualize how ILD responds to treatments across multiple centers involved in this NIH-sponsored research.See study design
What are the potential side effects?
Since the intervention involves an MRI scan using a special gas called Hyperpolarized Xenon-129, side effects might include discomfort from holding one's breath during scanning and potential claustrophobia inside the MRI machine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Coefficient of repeatability of RBC/barrier signal ratio (unitless).
Echo time to separate RBC and barrier signals by 90 degrees (ms).
Population-wide RBC/barrier signal ratio (unitless).
+2 moreTrial Design
2Treatment groups
Active Control
Group I: Healthy VolunteersActive Control1 Intervention
Group II: Patients with Interstitial Lung DiseaseActive Control1 Intervention
Find a Location
Who is running the clinical trial?
University of CincinnatiOTHER
428 Previous Clinical Trials
634,247 Total Patients Enrolled
Children's Hospital Medical Center, CincinnatiOTHER
815 Previous Clinical Trials
6,531,444 Total Patients Enrolled
University of IowaOTHER
447 Previous Clinical Trials
879,575 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your oxygen level while resting is less than 90% on room air.I have a history of irregular heartbeats from the lower chambers of my heart.The person cannot fit into the MRI 129 Xe vest coil.You are unable to hold your breath for 15 seconds.I haven't had a lung infection in the last 30 days.I am under 18 years old.I am 18 years old or older and not hospitalized.I have been diagnosed with Interstitial Lung Disease by a lung specialist.I had a cardiac arrest in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Volunteers
- Group 2: Patients with Interstitial Lung Disease
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there available capacity for new enrollees in this trial?
"Affirmative. Clinicaltrials.gov data affirms that the trial, initially posted on November 12th 2021 is still actively recruiting patients. The study requires 147 participants from 4 distinct sites to be enrolled by its completion date."
Answered by AI
What is the current enrollment rate for this clinical trial?
"To carry out this trial, we require 147 participants who qualify for the stated inclusion criteria. Patients can take part in this research from a variety of places including Duke University Medical Center and University of Iowa."
Answered by AI
Has the FDA approved any treatments for Interstitial Lung Disease patients?
"Based on the currently available data, our team at Power rated the safety of ILD patients a 2 out of 3. This estimation is due to it being a Phase 2 trial which has shown some evidence for safety but not efficacy."
Answered by AI
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