LUng voluMe reductIoN by DuAl ENergy CT Evaluation (LUMINANCE) Study

The purpose of this research study is to see if a special CT scan (dual-energy CT) provides useful information in patients undergoing bronchsoscopic lung volume reduction (valve placement for emphysema). The investigators will enroll up to 30 participants in this study from University Hospitals Cleveland Medical Center. All of the participants from this study will undergo their valve procedure at University Hospitals Cleveland Medical Center.

Study Overview

• Status: Completed
• Conditions: Lung Perfusion
• Intervention / Treatment: Procedure: Dual Energy CT

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Up to 30 patients within the University Hospitals Health System

Description

Inclusion Criteria:

• Adult patients (≥ 18 years of age at the time of written informed consent) with emphysema who have been deemed appropriate candidates for bronchoscopic lung volume reduction

Exclusion Criteria:

• Patients unable to provide consent
• Patients who are pregnant or nursing
• Women of child-bearing age will undergo pregnancy tests based on University Hospital (UH) standard bronchoscopy pre-procedural testing
• Patients unable to undergo a DECT chest (contraindications to a CT chest with intravenous contrast such as a reported or documented allergy to intravenous (IV) contrast or impaired renal function, defined as the following:
• Glomerular filtration rate (GFR) <90 ml/min/1.73 m2 at the time of initial evaluation if patient age is ≤ 59 years
• GFR <85 ml/min/1.73 m2 if patient age is 60-69 years
• GFR <75 ml/min/1.73 m2 if patient age is ≥70 years

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients being evaluated for bronchoscopic lung volume reduction (BLVR).	Procedure: Dual Energy CT; Patient will receive Dual Energy CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in lung perfusion as measured by duel-energy computed tomography	Baseline, 8 weeks
Change in walk distance as measured by six-minute walk test	Baseline, 8 weeks
Change in FEV1 as measured by pulmonary function test	Baseline, 8 weeks

Collaborators and Investigators

• Sponsor: Sameer Avasarala
• Investigators: Principal Investigator: Sameer Avasarala, MD, University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Actual): May 24, 2025
• Study Completion (Actual): May 24, 2025

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STUDY20221082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No