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

NCT ID: NCT05816239

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-24

Study Completion Date

2025-05-24

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Perfusion

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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

Dual Energy CT

Intervention Type PROCEDURE

Patient will receive Dual Energy CT

Interventions

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Dual Energy CT

Patient will receive Dual Energy CT

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sameer Avasarala

OTHER

Sponsor Role lead

Responsible Party

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Sameer Avasarala

Assistant Professor of Medicine, Case Western Reserve University School of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sameer Avasarala, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals

Locations

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University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY20221082

Identifier Type: -

Identifier Source: org_study_id

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