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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pulmonary Disease Subjects: Symptoms - chronic shortness of breath
Symptoms - chronic shortness of breath
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the accuracy of computer models that simulate airflow in the lungs of patients with lung disease.
Who is the study for?
This trial is for adults who are similar in height and age, with or without Chronic Obstructive Pulmonary Disease (COPD). Healthy participants should never have smoked and must have normal lung function tests. COPD patients need to show specific levels of lung obstruction. People can't join if they're claustrophobic, too large for the MRI equipment, pregnant, or have non-MRI safe metal in their body.
What is being tested?
The study uses a special type of chest MRI with helium gas to measure airflow in the lungs. It aims to validate computer models that predict airflow issues by comparing actual measurements from healthy individuals and those with lung disease.
What are the potential side effects?
There may be minimal side effects related to lying still inside an MRI machine; however, risks include discomfort due to tight spaces (claustrophobia) or reactions if not compatible with MRI environments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have chronic shortness of breath.
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I experience chronic shortness of breath.
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My chest X-ray shows lung over-expansion but is otherwise normal.
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I have never smoked and have no lung problems or symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Hyperpolarized helium MRI flow velocity map
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Hyperpolarized helium MRI of the chestExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
782 Previous Clinical Trials
1,315,715 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My age is within 3 years of the other participants.I have chronic shortness of breath.Both healthy individuals and those with COPD should have similar physical body measurements.Your height is close to the same as the other person (within 3-4 inches).Healthy subjects must have normal lung function tests, with FEV1 and FVC values both being higher than 90% of what is expected.My height matches the study's requirements.I experience chronic shortness of breath.You have a normal chest x-ray.Your lung function tests show signs of obstruction and your FEV1 is between 30% and 50% of what is expected.I have a lung condition.My chest X-ray shows lung over-expansion but is otherwise normal.I have never smoked and have no lung problems or symptoms.You might feel very uncomfortable in small or enclosed spaces.Your chest is too big to fit inside the MRI machine.You have a condition that makes it unsafe for you to have an MRI scan.
Research Study Groups:
This trial has the following groups:- Group 1: Hyperpolarized helium MRI of the chest
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.
Chronic Obstructive Pulmonary Disease Patient Testimony for trial: Trial Name: NCT02154568 — N/A
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