NCT03776747

Brief Summary

The main purpose of this study is to assess and test the reproducibility and results of hyperpolarized 3-Helium gas as a contrast agent with Magnetic Resonance Imaging (MRI) of the lungs in healthy adult subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2018

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

November 1, 2023

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

3.9 years

First QC Date

December 13, 2018

Results QC Date

December 6, 2022

Last Update Submit

October 10, 2023

Conditions

Radiation Exposure

Outcome Measures

Primary Outcomes (1)

  • Apparent Diffusion Coefficient (ADC) as a Function of Lung Inflation Levels.

    Validate the intrinsic variability of ADC (cm2/s) as a function of normal procedural and physiological changes in an attempt to standardize the use of the biomarker in future assessments of pulmonary pathologies.

    Through study completion, measurements completed at one day visit only.

Study Arms (2)

Group One: Prone MRI Scans

EXPERIMENTAL

Subjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan

Drug: Prone hyperpolarized 3 helium gas scanDiagnostic Test: VitalsDiagnostic Test: Pulmonary Function TestsDiagnostic Test: Initial protocol MRI scan

Group Two: Supine MRI scans

ACTIVE COMPARATOR

Subjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan

Drug: Supine hyperpolarized 3 helium gas scanDiagnostic Test: VitalsDiagnostic Test: Pulmonary Function TestsDiagnostic Test: Initial protocol MRI scan

Interventions

Prone hyperpolarized 3 helium gas scanDRUG

Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is prone.

Also known as: Prone MRI scan with contrast
Group One: Prone MRI Scans
Supine hyperpolarized 3 helium gas scanDRUG

Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is supine.

Also known as: Supine MRI scan with contrast
Group Two: Supine MRI scans
VitalsDIAGNOSTIC_TEST
Group One: Prone MRI ScansGroup Two: Supine MRI scans
Pulmonary Function TestsDIAGNOSTIC_TEST

Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes

Group One: Prone MRI ScansGroup Two: Supine MRI scans
Initial protocol MRI scanDIAGNOSTIC_TEST

Initial scan to determine placement

Group One: Prone MRI ScansGroup Two: Supine MRI scans

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • must be between the ages of 18 and 90
  • must have a Body Mass Index (BMI) of \< 32 and weigh \< 200 lbs.

You may not qualify if:

  • if female, must not be pregnant or breastfeeding
  • must not have any metal objects in or on their body including body piercings that cannot be easily removed, bullets, metallic fragments or slivers in eyes, skin, etc., pacemaker or defibrillation, aneurysm clips, cochlear implants, coronary stents, or neurostimulation.
  • must not have a history of claustrophobia, panic disorders, anxiety attacks, atrial fibrillation, uncontrolled high blood pressure, frequent ventricular ectopic rhythm, hemodynamic instability, kidney dysfunction or heart disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Interventions

Contrast MediaRespiratory Function Tests

Intervention Hierarchy (Ancestors)

Diagnostic Uses of ChemicalsPharmacologic ActionsChemical Actions and UsesSpecialty Uses of ChemicalsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Dr. Eric Hoffman
Organization
University of Iowa
eric-hoffman@uiowa.edu
(319) 356-1381

Study Officials

  • Eric A Hoffman, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 13, 2018

First Posted

December 17, 2018

Study Start

July 22, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

November 1, 2023

Results First Posted

November 1, 2023

Record last verified: 2023-10

Locations

US(1)