Lung CancerNCT03426306
A Novel Lung Function Imaging Modality As a Preoperative Evaluation Tool (LIME)
A study testing 4DCT-Ventilation in people with Lung Cancer, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
To evaluate the correlation between pre-surgical 4DCT-ventilation imaging and post-surgical lung function. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- 4DCT-Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Mar 2018to 18 Jan 2022
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision to sign and date the consent form.
- Stated willingness to comply with all required (non-optional) study procedures and be available for the duration of the study.
- Be a male or female aged 18 to 100.
- Patient with lung cancer (presumed or biopsy proven) currently undergoing or having undergone evaluation for resection.
- Lung function assessment required for pre-surgical evaluation at the discretion of the cardiothoracic surgeon.
- Life expectancy greater than 3 months.
Who cannot join
- 1. Patients getting a planned wedge resection as the only thoracic resectional procedure.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Denver
Aurora, Colorado, 80045
UCHealth Memorial Hospital
Colorado Springs, Colorado, 80920
About this study
To evaluate the correlation between pre-surgical 4DCT-ventilation imaging and post-surgical lung function.
Read the detailed description
To evaluate the correlation between pre-surgical 4-Dimensional Computed Tomography-ventilation (4DCT-ventilation) imaging and post-surgical lung function. To determine whether 4DCT-ventilation is a better predictor of post-surgical lung function than nuclear medicine imaging using pulmonary function tests (PFTs). To determine whether 4DCT-ventilation is a better predictor of post-surgical lung function than nuclear medicine imaging using quality of life (QOL) questionnaires. Evaluate cost-effectiveness of using 4DCT-ventialtion and VQ scans for pre-surgical assessment. To use longitudinal (pre and post-surgical) 4DCT-ventilation imaging to derive novel post-surgical prediction formulas.
- Conditions
- Lung Cancer
- Being tested
- 4DCT-Ventilation
- Keywords
- 4-Dimensional Computed Tomography
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4DCT-VentilationDiagnostic test
4DCT-ventilation is an imaging modality that provides superior image quality, reduced cost, and a faster imaging procedure compared to nuclear medicine VQ scans.
| Study group | Role | What they receive |
|---|---|---|
| 4DCT-ventilation | Experimental | The patient will undergo 4DCT imaging. The 4DCT imaging data along with image processing techniques will be used to generate a 4DCT-ventilation map. All surgical decisions will be based on the current standard of care imaging (VQ scans) and not on the 4DCT imaging results. Receives: Diagnostic Test: 4DCT-Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-Surgical Imaging and Post-Surgical Lung Function
Measure the correlation between pre-surgical 4-Dimensional Computed Tomography-ventilation (4DCT) imaging and post surgical lung function using a Percent Predicted Post-Operative Pulmonary Function Test (%PPO PFT).
Measured: Baseline visit to follow up visit, up to 9 months.
Secondary outcomes (4)
Ability of %PPO PFTs
Use %PPO PFTs to determine if 4DCT-ventilation is a better predictor of post surgical lung function than nuclear medicine imaging
Measured: Start of study to end of study, up to 2 years
Quality of Life (QOL)
Use QOL questionnaires to determine if 4DCT-ventilation is a better predictor of post surgical lung function than nuclear medicine imaging.
Measured: Start of study to end of study, up to 2 years
Cost-Effectiveness
Determine the cost-effectiveness of 4DCT-ventialtion and VQ scans for pre-surgical assessment using Receiver Operator Characteristic (ROC) analysis.
Measured: Start of study to end of study, up to 2 years
Longitudinal Imaging Changes
Derive novel post-surgical prediction formulas using longitudinal 4DCT-ventilation imaging
Measured: Start of study to end of study, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start21 Mar 2018
- Primary completion18 Jan 2022
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard Jones, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426306
- Sponsor's protocol ID
- 17-2216.cc
- Status last verified
- Sep 2024
- First submitted
- 1 Feb 2018
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Lung Function Imaging Modality As a Preoperative Evaluation Tool (LIME)
- ClinicalTrials.gov ID
- NCT03426306
- Acronym / sponsor ID
- 17-2216.cc
- Conditions
- Lung Cancer
- Keywords
- 4-Dimensional Computed Tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 8 Feb 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.
To evaluate the correlation between pre-surgical 4DCT-ventilation imaging and post-surgical lung function.
Detailed description
To evaluate the correlation between pre-surgical 4-Dimensional Computed Tomography-ventilation (4DCT-ventilation) imaging and post-surgical lung function. To determine whether 4DCT-ventilation is a better predictor of post-surgical lung function than nuclear medicine imaging using pulmonary function tests (PFTs). To determine whether 4DCT-ventilation is a better predictor of post-surgical lung function than nuclear medicine imaging using quality of life (QOL) questionnaires. Evaluate cost-effectiveness of using 4DCT-ventialtion and VQ scans for pre-surgical assessment. To use longitudinal (pre and post-surgical) 4DCT-ventilation imaging to derive novel post-surgical prediction formulas.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4DCT-ventilation | Experimental | Diagnostic Test: 4DCT-VentilationThe patient will undergo 4DCT imaging. The 4DCT imaging data along with image processing techniques will be used to generate a 4DCT-ventilation map. All surgical decisions will be based on the current standard of care imaging (VQ scans) and not on the 4DCT imaging results. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision to sign and date the consent form.
- Stated willingness to comply with all required (non-optional) study procedures and be available for the duration of the study.
- Be a male or female aged 18 to 100.
- Patient with lung cancer (presumed or biopsy proven) currently undergoing or having undergone evaluation for resection.
- Lung function assessment required for pre-surgical evaluation at the discretion of the cardiothoracic surgeon.
Key exclusion criteria (1 listed)
- 1. Patients getting a planned wedge resection as the only thoracic resectional procedure.
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 |
|---|---|---|
| 4DCT-Ventilation4DCT-ventilation is an imaging modality that provides superior image quality, reduced cost, and a faster imaging procedure compared to nuclear medicine VQ scans. | Diagnostic test | 4DCT-ventilation |
Primary outcome
Pre-Surgical Imaging and Post-Surgical Lung Function
Time frame: Baseline visit to follow up visit, up to 9 months.
Measure the correlation between pre-surgical 4-Dimensional Computed Tomography-ventilation (4DCT) imaging and post surgical lung function using a Percent Predicted Post-Operative Pulmonary Function Test (%PPO PFT).
4 secondary outcomes
Ability of %PPO PFTs
Time frame: Start of study to end of study, up to 2 years
Quality of Life (QOL)
Time frame: Start of study to end of study, up to 2 years
Cost-Effectiveness
Time frame: Start of study to end of study, up to 2 years
Longitudinal Imaging Changes
Time frame: Start of study to end of study, up to 2 years
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 19 Sep 2024.
- 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.
Bernard Jones principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4DCT-Ventilation in people with Lung Cancer, run by University of Colorado, Denver at 2 sites 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 6 inclusion and 1 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Pre-Surgical Imaging and Post-Surgical Lung Function (time frame: Baseline visit to follow up visit, up to 9 months.). 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 19 Sep 2024.