Recruiting

Helium-3, Xenon-129

Sponsor:

Dr. Grace Parraga

Code:

NCT02279329

Conditions

COPD

Bronchiectasis

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Hyperpolarized Helium MRI

Study Details

Brief summary:

Subjects male and female aged 50-85 with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) or Bronchiectasis, or those with ≥ 10 pack/years smoking history will be imaged with CT and MRI for the development of tools to quantify and validate longitudinal in vivo magnetic resonance imaging phenotypes of COPD and Bronchiectasis.

Conditions

COPD

Bronchiectasis

Study ID

NCT02279329

Start date

May, 2009

Status verified date

Jun, 2024

Completion date

Feb, 2025

Anticipated

Primary completion date

Feb, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subjects male and female aged 50-85 with either A) a clinical diagnosis of COPD or Bronchiectais or B) >10 pack/year smoking history
  • Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent
  • Subject must be able to perform a breathhold for 16s.
  • Subject is judged to be in otherwise stable health on the basis of medical history
  • Subject is ambulatory and can perform the 6MWT
  • Subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.)
  • FEV1 >25% predicted
  • FVC > 25% predicted and >0.5L

Exclusion Criteria:

  • Patient is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material.
  • Subject has a daytime room air oxygen saturation <90% while lying supine.
  • Patient is unable to perform spirometry or plethysmography maneuvers
  • Patient is pregnant
  • In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia.
  • Subject has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants.)

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: COPD and Bronchiectasis Patients

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.

Interventions

Hyperpolarized Helium MRI

Hyperpolarized helium-3 (3He) magnetic resonance imaging (MRI) has recently emerged as another research approach for the non-invasive measurement of lung structure and function, including conduction of gas through airways and into airspaces. Preliminary studies suggest that 3He MRI may be ideally suited for longitudinal COPD research, which is a likely target application of this novel technology. 3He MRI provides a complementary and alternative method for evaluating COPD and may be superior to CT because it allows simultaneous visualization of both airway and airspace structure and function.

Primary outcome measure

  • Ventilation Defect Percent (VDP) [ Time Frame: 3 years ]
  • Apparent Diffusion Coefficients (ADC) [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Grace E Parraga, PhD

519-931-5265gparraga@robarts.ca

Angela P Wilson, RRT

519-931-5777awilson@robarts.ca

Locations

Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5B7

Contacts

Grace E Parraga, PhD

519-931-5265gparraga@robarts.ca

More Information

Sponsor

Dr. Grace Parraga

Last update posted

Jun 13, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Grace Parraga on 2024-06-13.