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NCT06856525 · ClinicalTrials.gov registry record · Phase 2

Dissolved Phase HXe-129 MRI: A Novel Biomarker to Quantify Pulmonary Pathology

A Phase 2 study of Electronic Cigarette Related Lung Damage, sponsored by Y. Michael Shim, MD.

Recruiting
Registry status
Phase 2
Development phase
80
Enrollment target
2
Study locations

NCT06856525: Recruiting Phase 2 study of Electronic Cigarette Related Lung Damage, sponsored by Y. Michael Shim, MD.

NCT06856525 is a Phase 2 study of Electronic Cigarette Related Lung Damage that is actively recruiting participants, run by Y. Michael Shim, MD. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06856525, a Phase 2 study of Electronic Cigarette Related Lung Damage, is actively recruiting participants, sponsored by Y. Michael Shim, MD.

RECRUITING
Registry status
Phase 2
Development phase
80 participants
Enrollment target
2
Study locations

Study Summary

A two-center, longitudinal assessment of 40 electronic cigarette users and 40 healthy controls at the initial visit and a follow-up visit 12 months later. This study will determine the impact of electronic cigarette use on pulmonary gas exchange capacity and then corroborate the Hyperpolarized Xenon MRI (HXeMRI) results with the cardiopulmonary stress test at the initial visit and a follow-up visit 12 months later.

Primary Outcome

Hyperpolarized MRI (ventilation defect, RBC/Gas, Membrane/Gas, and RBC/membrane numbers) capillaries using HXeMRI, and corroborate the HXeMRI signatures with the CPET for 40 healthy participants and 40 e-cigarette users use at an initial visit (V1) and a follow-up visit 12-months later (V2).

Interventions

  • DRUG Hyperpolarized xenon 129
  • DIAGNOSTIC_TEST Cardiopulmonary Stress Test
  • DIAGNOSTIC_TEST Pulmonary Function Test
  • DIAGNOSTIC_TEST Chest CT

Study Locations (2)

North Carolina

  • Duke University - Durham

Virginia

  • University of Virginia - Charlottesville

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2024-12-19
Est. Completion 2032-12-31
Phase Phase 2
Y. Michael Shim, MD

1 total trials

What NCT06856525 shows while recruiting

NCT06856525 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).

The record links to 1 condition, with Electronic Cigarette Related Lung Damage appearing as the primary indexed condition, and to 4 interventions - of which Hyperpolarized xenon 129 is the first listed.

NCT06856525 reports a single indexed study location in North Carolina, Virginia.

Frequently Asked Questions

What is clinical trial NCT06856525 about?

NCT06856525 is a clinical study titled "Dissolved Phase HXe-129 MRI: A Novel Biomarker to Quantify Pulmonary Pathology". A two-center, longitudinal assessment of 40 electronic cigarette users and 40 healthy controls at the initial visit and a follow-up visit 12 months later. This study will determine the impact of electronic cigarette use on pulmonary gas exchange capacity and then corroborate the Hyperpolarized Xenon...

What is the current status of trial NCT06856525?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2024-12-19. Estimated completion is 2032-12-31.

What conditions does trial NCT06856525 study?

This clinical trial studies the following conditions: Electronic Cigarette Related Lung Damage.

What interventions are being tested in trial NCT06856525?

The interventions under investigation include: Hyperpolarized xenon 129 (DRUG), Cardiopulmonary Stress Test (DIAGNOSTIC_TEST), Pulmonary Function Test (DIAGNOSTIC_TEST), Chest CT (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT06856525?

This trial is sponsored by Y. Michael Shim, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06856525 being conducted?

This trial has 2 study locations across North Carolina, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06856525's enrollment target sits among peer trials

80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06856525, the US trial registry maintained by the National Library of Medicine. NCT06856525 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.