Lung PerfusionNCT05816239
LUng voluMe reductIoN by DuAl ENergy CT Evaluation (LUMINANCE) Study
An observational study of Lung Perfusion, run by Sameer Avasarala at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Perfusion
- What is being tested?
- Dual Energy CT
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2023to 24 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 30 patients within the University Hospitals Health System
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this 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.
- Conditions
- Lung Perfusion
- Being tested
- Dual Energy CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Energy CTProcedure or surgery
Patient will receive Dual Energy CT
| Study group | Role | What they receive |
|---|---|---|
| Patients being evaluated for bronchoscopic lung volume reduction (BLVR). | Not described Receives: Procedure: Dual Energy CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lung perfusion as measured by duel-energy computed tomography
Measured: Baseline, 8 weeks
Change in walk distance as measured by six-minute walk test
Measured: Baseline, 8 weeks
Change in FEV1 as measured by pulmonary function test
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start24 Feb 2023
- Primary completion24 May 2025
- Study completion24 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung PerfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sameer Avasarala
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sameer Avasarala, University Hospitals Cleveland Medical Center
- Investigators
- Sameer Avasarala, MD, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816239
- Sponsor's protocol ID
- STUDY20221082
- Status last verified
- Aug 2025
- First submitted
- 30 Mar 2023
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUng voluMe reductIoN by DuAl ENergy CT Evaluation (LUMINANCE) Study
- ClinicalTrials.gov ID
- NCT05816239
- Acronym / sponsor ID
- STUDY20221082
- Conditions
- Lung Perfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Sameer AvasaralaUniversity, hospital or other
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 24 May 2025 (actual)
- Study completion
- 24 May 2025 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients being evaluated for bronchoscopic lung volume reduction (BLVR). | – | Procedure: Dual Energy CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 30 patients within the University Hospitals Health System
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual Energy CTPatient will receive Dual Energy CT | Procedure or surgery | Patients being evaluated for bronchoscopic lung volume reduction (BLVR). |
Primary outcome
Change in lung perfusion as measured by duel-energy computed tomography
Time frame: Baseline, 8 weeks
Change in walk distance as measured by six-minute walk test
Time frame: Baseline, 8 weeks
Change in FEV1 as measured by pulmonary function test
Time frame: Baseline, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameer Avasarala, MD principal investigator
University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Perfusion, run by Sameer Avasarala at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lung perfusion as measured by duel-energy computed tomography (time frame: Baseline, 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.