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

NCT05816239 | Completed DMC

• 1 other identifier: STUDY20221082
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Perfusion

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Patients being evaluated for bronchoscopic lung volume reduction (BLVR).

Procedure: Dual Energy CT

Interventions

Dual Energy CT PROCEDURE

Patient will receive Dual Energy CT

Patients being evaluated for bronchoscopic lung volume reduction (BLVR).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 30 patients within the University Hospitals Health System

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sameer Avasarala: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Study Officials

• Sameer Avasarala, MD

  University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Case Western Reserve University School of Medicine

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 18, 2023
• Study Start: February 24, 2023
• Primary Completion: May 24, 2025
• Study Completion: May 24, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)