Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy

NCT03331302 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 20053
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Hyper polarized Xenon-129 MRI will be directly compared to a radioactive Xe-133 scintigraphy to detect defects in lung ventilation from airflow limitation. This study is conducted as a pilot study with intention to conduct a larger clinical trial.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Ventilation imaging resolution comparison between MRI and scintigraphy

  Compare the quality of the imaging between hyper polarized xenon-129 and radioactive xenon-133

  12 months

Study Arms (2)

COPD patients - Xe-133

ACTIVE COMPARATOR

COPD patients who will be assessed with Xenon-133 scintigraphy (Standard diagnostic study)

Drug: Radioactive Xenon-133 scintigraphy (Active Comparator)

COPD patients - Hyperpolarized Xe-129

EXPERIMENTAL

COPD patients crossed over from the Active Comparator Arm who will be assessed with hyper polarized Xenon-129 MRI (Experimental diagnostic study)

Drug: Hyperpolarized Xenon-129 MRI (Experimental)

Interventions

Hyperpolarized Xenon-129 MRI (Experimental) DRUG

MRI ventilation scan of the lung with inhaled contrast agent (hyperpolarized Xenon-129)

Also known as: Polarean Pilot study

COPD patients - Hyperpolarized Xe-129

Radioactive Xenon-133 scintigraphy (Active Comparator) DRUG

Radioactive ventilation scintigraphy of the lung with inhaled radioactive contrast agent (Xenon-133)

Also known as: Pilot study

COPD patients - Xe-133

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have a diagnosis of COPD
• at their clinical baseline on the day of imaging
• must be clinically stable in order to participate in the study.
• COPD subjects will be categorized according to the GOLD
• Current/Former SmokerSubjects
• must have a smoking history ≥ 10 pack years

You may not qualify if:

• Dx of asthma
• Continuous oxygen use at home
• Blood oxygen saturation of 92% less than as measured by pulse oximetry on the day of imaging
• FEV1 percent predicted less than 25%
• Pregnancy or lactation
• Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning
• Subjects with any implanted device that cannot be verified as MRI compliant will be excluded
• Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches
• History of congenital cardiac disease, chronic renal failure, or cirrhosis
• Inability to understand simple instructions or to hold still for approximately 10 seconds
• History of respiratory infection within 2 weeks prior to the MR scan
• History of MI, stroke and/or poorly controlled hypertension.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Pilot Projects

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Evaluation Studies as Topic; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Yun M Shim, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Struchen, RN

CONTACT

4342436074; SS8YM@hscmail.mcc.virginia.edu

Roselove Nunoo-Asare, RT

CONTACT

4342437363; RNN3B@hscmail.mcc.virginia.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: COPD patients with standard vs study diagnostic methods (imaging procedures)

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 6, 2017
• Study Start: September 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

US (1)