Phase 4
Completed N=18
Repeatability in Hyperpolarized 3-Helium With MRI
Radiation Exposure
Source: ClinicalTrials.gov NCT03776747 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Apparent Diffusion Coefficient (ADC) as a Function of Lung Inflation Levels. — 0.167; 0.175; 0.188 ADC (cm2/sec) — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apparent Diffusion Coefficient (ADC) as a Function of Lung Inflation Levels. |
0.167; 0.175; 0.188 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- must be between the ages of 18 and 90
- must have a Body Mass Index (BMI) of < 32 and weigh < 200 lbs.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03776747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.