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

Conditions

• Electronic Cigarette Related Lung Damage

Eligibility Criteria

Sex

ALL

Age

18 Years - 35 Years

Healthy Volunteers

Accepted

Interventions

• Hyperpolarized xenon 129 — DRUG
  Determine the impact of e-cigarette use on pulmonary gas exchange capacity in interstitial tissues and capillaries using hyperpolarized xenon-129 MRI.
• Cardiopulmonary Stress Test — DIAGNOSTIC_TEST
  Exercise stress test to evaluate cardiac and pulmonary fitness.
• Pulmonary Function Test — DIAGNOSTIC_TEST
  Standard clinic pulmonary function test to evaluate lung function
• Chest CT — DIAGNOSTIC_TEST
  Clinical standard chest computer tomography to evaluate any lung tissue scars or air movement.

Study Details

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.

Key Dates

Start date

Dec 19, 2024

Status verified

Mar 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2032

Study Design

Enrollment

80 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Other: Healthy Participants
  Young, healthy subjects without any lung disease or other inflammatory diseases.
• Experimental: eCig user
  Young, otherwise healthy subjects who have used electronic cigarettes for at least 6 months past year.

Primary Outcome Measure

Comparison between e-cig user vs. healthy participants at baseline and 12 month later [ Time Frame: baseline and 12 month follow-up ]

Central Contacts

• Roselove Asare, MA
  4342436074
  [email protected]
• Caleigh Smith, BS
  434-243-1140
  [email protected]

Locations (2)

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