Pulmonary Disease, Chronic ObstructiveEarly Phase 1NCT03764163
Image and Model Based Analysis of Lung Disease
A Early Phase 1 study testing Pulmonary Function Test, CT Scans and Questionnaires in people with Pulmonary Disease, Chronic Obstructive, run by Eric A. Hoffman at 1 site in United States.
Trial summary
The purpose of this research study is to develop CT scanning and image analysis techniques to help define and measure several key properties of the pulmonary system that cannot be obtained by other tests or exams. Read more about this study
- Who is it for?
- Ages 20 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Pulmonary Function Test, CT Scans and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 1997to 5 Jun 2015
- Phase
- Early Phase 1
- 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 20 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non smokers, age 20-29, 40-49, 60-69, 80-89, cannot have smoked more than 20 cigarettes in their lifetime
- Smokers, age 20-29, 40-49, 60-69, 80-89, currently smoking a minimum of 1 pack (20 cigarettes) per day, normal smokers and mild to moderate Chronic Obstructive Pulmonary Disease (COPD)
Who cannot join
- Allergies - no allergies to shellfish, eggs, iodine
- Medications - no medications (except for birth control) for in the 'normal' category
- No asthma - as self reported
- BMI (Body Mass Index) - must not exceed 32 or 100kg of weight
- No other radiology studies in the last 12 months
- No metal in lung field - no metal from larynx to stomach
Show all 9Show fewer
- No known heart disease
- No known kidney disease or diabetes
- Must not be pregnant - subjects of childbearing potential with be given a urine pregnancy test
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
The purpose of this research study is to develop CT scanning and image analysis techniques to help define and measure several key properties of the pulmonary system that cannot be obtained by other tests or exams.
Read the detailed description
Specifically, the investigators are interested in understanding the difference between the normal aging process and the events that lead to emphysema. Additionally, the investigators are interested in understanding the earliest signs (lung inflammation) of the disease process leading to three lung diseases, which include emphysema, fibrosis and sarcoidosis; all of which are described as "inflammatory lung diseases." The investigators will be using the data from this study to help define the normal values for the measured properties as well as deviation from normal values in smokers without defined lung disease and patients with inflammatory lung disease. The investigators believe that the analysis and scanning techniques being developed as part of this research will provide new and previously unavailable information on normal and diseased lungs so that ultimately the investigators can detect specific changes in the lungs due to a disease and measure any improvements in the anatomy and/or function of the pulmonary system after a patient has undergone treatment. This study involves research using X-Ray computed tomography (CT) scanner, which is similar to previous CT scanners but operates much faster and provides finer image detail.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Pulmonary Function Test, CT Scans, Questionnaires, MRI, Xenon gas
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Function TestDiagnostic test
Spirometry, Diffusing Capacity of the Lungs (DLCO), Lung Volumes
CT ScansDiagnostic test
volume scans, perfusion scan, ventilation scan
QuestionnairesBehavioural
Human Subjects Questionnaire, Baseline Dyspnea Index, Chronic Respiratory Questionnaire
MRIDiagnostic test
proton scans, hyperpolarized 3-Helium scan
Xenon gasBiological
ventilation CT scans
| Study group | Role | What they receive |
|---|---|---|
| Study Participants | Experimental | Pulmonary Function Test, Questionnaires, CT scans, perfusion scan, ventilation scan, Xenon gas ventilation CT scan with hyperpolarized 3-Helium MRI Scan. Receives: Diagnostic Test: Pulmonary Function Test; Diagnostic Test: CT Scans; Behavioral: Questionnaires; Diagnostic Test: MRI; Biological: Xenon gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal lung aging assessed by CT imaging
Normal aging process of the lungs compared to common smoking related lung diseases.
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start30 Sep 1997
- Primary completion5 Jun 2015
- Study completion5 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eric A. Hoffman
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Eric A. Hoffman, University of Iowa
- Investigators
- Eric A Hoffman, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764163
- Sponsor's protocol ID
- 199708651
- Other IDs
- 5R01HL064368
- Status last verified
- Jan 2019
- First submitted
- 30 Mar 2018
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: CT images will be shared including non-contrast images at TLC, FRC and RV as well as dual energy CT image data used to assess regional perfused blood volume. All associated pulmonary function test results will be shared. CT-derived metrics
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image and Model Based Analysis of Lung Disease
- ClinicalTrials.gov ID
- NCT03764163
- Acronym / sponsor ID
- 199708651
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Eric A. HoffmanUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 30 Sep 1997 (actual)
- Primary completion
- 5 Jun 2015 (actual)
- Study completion
- 5 Jun 2015 (actual)
- First posted
- 4 Dec 2018 (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 develop CT scanning and image analysis techniques to help define and measure several key properties of the pulmonary system that cannot be obtained by other tests or exams.
Detailed description
Specifically, the investigators are interested in understanding the difference between the normal aging process and the events that lead to emphysema. Additionally, the investigators are interested in understanding the earliest signs (lung inflammation) of the disease process leading to three lung diseases, which include emphysema, fibrosis and sarcoidosis; all of which are described as "inflammatory lung diseases." The investigators will be using the data from this study to help define the normal values for the measured properties as well as deviation from normal values in smokers without defined lung disease and patients with inflammatory lung disease. The investigators believe that the analysis and scanning techniques being developed as part of this research will provide new and previously unavailable information on normal and diseased lungs so that ultimately the investigators can detect specific changes in the lungs due to a disease and measure any improvements in the anatomy and/or function of the pulmonary system after a patient has undergone treatment. This study involves research using X-Ray computed tomography (CT) scanner, which is similar to previous CT scanners but operates much faster and provides finer image detail.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Participants | Experimental | Diagnostic Test: Pulmonary Function Test, Diagnostic Test: CT Scans, Behavioral: Questionnaires, Diagnostic Test: MRI, Biological: Xenon gasPulmonary Function Test, Questionnaires, CT scans, perfusion scan, ventilation scan, Xenon gas ventilation CT scan with hyperpolarized 3-Helium MRI Scan. |
Who may qualify
- Ages
- 20 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non smokers, age 20-29, 40-49, 60-69, 80-89, cannot have smoked more than 20 cigarettes in their lifetime
- Smokers, age 20-29, 40-49, 60-69, 80-89, currently smoking a minimum of 1 pack (20 cigarettes) per day, normal smokers and mild to moderate Chronic Obstructive Pulmonary Disease (COPD)
Key exclusion criteria (9 listed)
- Allergies - no allergies to shellfish, eggs, iodine
- Medications - no medications (except for birth control) for in the 'normal' category
- No asthma - as self reported
- BMI (Body Mass Index) - must not exceed 32 or 100kg of weight
- No other radiology studies in the last 12 months
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 |
|---|---|---|
| Pulmonary Function TestSpirometry, Diffusing Capacity of the Lungs (DLCO), Lung Volumes | Diagnostic test | Study Participants |
| CT Scansvolume scans, perfusion scan, ventilation scan | Diagnostic test | Study Participants |
| QuestionnairesHuman Subjects Questionnaire, Baseline Dyspnea Index, Chronic Respiratory Questionnaire | Behavioural | Study Participants |
| MRIproton scans, hyperpolarized 3-Helium scan | Diagnostic test | Study Participants |
| Xenon gasventilation CT scans | Biological | Study Participants |
Primary outcome
Normal lung aging assessed by CT imaging
Time frame: up to 10 years
Normal aging process of the lungs compared to common smoking related lung diseases.
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 22 Jan 2019.
- Individual participant dataSharing planned: Yes. CT images will be shared including non-contrast images at TLC, FRC and RV as well as dual energy CT image data used to assess regional perfused blood volume. All associated pulmonary function test results will be shared. CT-derived metrics
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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.
Eric A Hoffman, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pulmonary Function Test, CT Scans and Questionnaires in people with Pulmonary Disease, Chronic Obstructive, run by Eric A. Hoffman 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 2 inclusion and 9 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 22 Jan 2019. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Normal lung aging assessed by CT imaging (time frame: up to 10 years). 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 22 Jan 2019.