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Hyperpolarized Helium MRI for COPD Tracking

N/A

Recruiting

Led By Grace E Parraga, PhD

Research Sponsored by Dr. Grace Parraga

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is ambulatory and can perform the 6MWT

Subject must be able to perform a breathhold for 16s

Must not have

Patient is unable to perform spirometry or plethysmography maneuvers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is to develop imaging tools to track COPD and Bronchiectasis patients over time.

Who is the study for?

This trial is for men and women aged 50-85 with COPD, Bronchiectasis, or a significant smoking history (≥10 pack/years). Participants must be able to hold their breath for 16 seconds, walk on their own, perform specific lung function tests successfully, and have certain levels of lung capacity. Pregnant individuals or those with metal implants that can't be removed are excluded.

What is being tested?

The study involves using advanced MRI techniques with Helium-3 and Xenon-129 to image the lungs. It aims to develop tools for better understanding the changes in the lungs over time due to COPD or Bronchiectasis by comparing CT scans and MRIs.

What are the potential side effects?

While not explicitly listed in the provided information, typical side effects from MRI procedures may include discomfort from lying still during imaging, loud noises during scanning which might require ear protection, and potential feelings of claustrophobia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk on my own and can do a 6-minute walk test.

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I can hold my breath for 16 seconds.

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I am between 50-85 years old and have COPD, Bronchiectasis, or a smoking history of more than 10 pack-years.

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I can perform consistent lung function tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot perform certain lung function tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Apparent Diffusion Coefficients (ADC)

Ventilation Defect Percent (VDP)

Secondary study objectives

Six Minute Walk Distance (6MWD)

Spirometry

St. George's Respiratory Questionnaire (SGRQ)

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: COPD and Bronchiectasis PatientsExperimental Treatment1 Intervention

All enrolled COPD and Bronchiectasis patients will undergo Pulmonary Function Tests, Hyperpolarized Helium MRI, chest CT, 6-Minute Walk Test, and complete questionnaires at up to 8 visits over 2-3 years.

0 / 5Eligibility criteria met