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

Lung Perfusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05816239
• Other study ID #: STUDY20221082
• Status: Recruiting
• Start date: February 24, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: April 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: Jennie Pexa, RN
• Phone: 216-844-2381
• Email: Jennie.Pexa[@]UHhospitals.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Perfusion

Intervention

Procedure:
• Dual Energy CT
Patient will receive Dual Energy CT

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Sameer Avasarala

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in lung perfusion as measured by duel-energy computed tomography		Baseline, 8 weeks
Primary	Change in walk distance as measured by six-minute walk test		Baseline, 8 weeks
Primary	Change in FEV1 as measured by pulmonary function test		Baseline, 8 weeks