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Advanced Lung MRI Techniques for Lung Disease
Phase < 1
Recruiting
Led By Mitchell S Albert, PhD
Research Sponsored by Thunder Bay Regional Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to hold their breath for imaging: Healthy volunteers enrolled in this study must be able to hold their breath for 25 seconds. Lung disorder participants must be able to hold their breath for 15 seconds
Is either a healthy volunteer (i.e.: someone not diagnosed with a lung disorder written below; this may include smokers who have not been diagnosed with a lung disorder) or has been diagnosed with one of the following respiratory disorders: lung transplants, lung resection, lung cancer, asthma, cystic fibrosis, chronic obstructive pulmonary disease, emphysema, mesothelioma, asbestosis, pulmonary embolism, interstitial lung disease, pulmonary fibrosis, bronchiectasis, seasonal allergies, pneumonia, cold virus, lung infection, pulmonary hypertension, pulmonary dysplasia, obstructive sleep apnea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trialaims to improve MRI imaging of lungs using special contrast agents and coils tuned to their frequencies. Research to be conducted at TBRHSC Cardio & Res. MRI facility.
Who is the study for?
This trial is for healthy volunteers and those with various lung disorders who can consent, hold their breath (25 seconds for healthy individuals, 15 seconds for patients), and have no MR imaging contraindications like metal implants or pacemakers. Pregnant women, recent respiratory infection cases, certain Lakehead University students/employees are excluded.Check my eligibility
What is being tested?
The study aims to perfect MRI lung imaging using Hyperpolarized Noble Gases (HP 3He, HP 129Xe) and Inert Fluorinated Gases (PFP, SF6) as contrast agents. Participants will be imaged using specialized coils at TBRHSC's Cardiorespiratory Department and Research MRI facility.See study design
What are the potential side effects?
Since the trial involves MRI scans with inhaled gases used as contrast agents rather than drugs, typical drug side effects aren't expected. However, there may be risks associated with holding breath during imaging or potential discomfort from the use of nasal cannulas.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Healthy volunteers should be able to hold their breath for 25 seconds, and participants with lung disorders should be able to hold their breath for 15 seconds.
Select...
You are a healthy volunteer or have been diagnosed with specific lung disorders such as lung cancer, asthma, or chronic obstructive pulmonary disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Signal to Noise Ratio
Secondary outcome measures
Correlation with PFTs
Trial Design
2Treatment groups
Experimental Treatment
Group I: Lung Disorder ParticipantsExperimental Treatment7 Interventions
Participants will inhale investigational gases (HP 3He, HP 129Xe, PFP and SF6) according to the procedure for that intervention. All participants can potentially inhale all the gases. Magnetic resonance imaging will be performed during breath-holds or continuous breathing (gas-dependent) with the appropriate investigational human lung coil (3He Human Lung Coil, 129Xe Small and Large Human Lung Coil, or PFP and SF6 Human Lung Coil), using the 3T Research MRI at the Thunder Bay Regional Health Sciences Centre.
Group II: Healthy ParticipantsExperimental Treatment7 Interventions
Participants will inhale investigational gases (HP 3He, HP 129Xe, PFP and SF6) according to the procedure for that intervention. All participants can potentially inhale all the gases. Magnetic resonance imaging will be performed during breath-holds or continuous breathing (gas-dependent) with the appropriate investigational human lung coil (3He Human Lung Coil, 129Xe Small and Large Human Lung Coil, or PFP and SF6 Human Lung Coil), using the 3T Research MRI at the Thunder Bay Regional Health Sciences Centre.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perflutren
FDA approved
Find a Location
Who is running the clinical trial?
Thunder Bay Regional Research InstituteLead Sponsor
8 Previous Clinical Trials
674 Total Patients Enrolled
Thunder Bay Regional Health Research InstituteLead Sponsor
8 Previous Clinical Trials
674 Total Patients Enrolled
Thunder Bay Regional Health Sciences CentreOTHER
9 Previous Clinical Trials
3,350 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood oxygen level is less than 92% when measured while sitting and at rest, even if you normally use an oxygen nasal cannula.You have been scared of small, enclosed spaces in the past.You need to use an oxygen mask and cannot use a nasal cannula.You had a recent severe respiratory infection in the past 10 days.You are a healthy volunteer or have been diagnosed with specific lung disorders such as lung cancer, asthma, or chronic obstructive pulmonary disease.Healthy volunteers should be able to hold their breath for 25 seconds, and participants with lung disorders should be able to hold their breath for 15 seconds.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Participants
- Group 2: Lung Disorder Participants
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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.
How many participants has this trial recruited thus far?
"Indeed, clinicaltrials.gov's data shows that this scientific research is presently recruiting subjects. Initiated on November 10th 2020 and last updated October 25th 2022, the investigation requires 160 participants from a single centre."
Answered by AI
In what contexts is Healthy Participants typically utilized?
"Healthy Participants is usually prescribed to treat heightened upper airway resistance. Moreover, it has been useful in the management of echocardiography, cardiovascular diseases, and other forms of upper respiratory tract obstruction."
Answered by AI
Has research with healthy individuals been conducted to supplement this investigation?
"As of now, 46 studies are underway examining Healthy Participants. Among these trials, 3 have entered Phase 3. Most research sites for this treatment can be found in Philadelphia, Pennsylvania; however a total of 63 locations host experiments related to Healthy Participants."
Answered by AI
Are there any available spots left for participants in this experiment?
"Affirmative. Clinicaltrials.gov confirms that this medical research is still recruiting, having been initially published on November 10th 2020 and last edited on October 25th 2022. A total of 160 patients must be recruited from a single site."
Answered by AI
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