Lung CancerNCT06577883
Next Generation Chest X-Ray Tomosynthesis for Screening of Lung Cancer
An observational study of Lung Cancer, run by University of California, San Diego at 1 site in United States.
Trial summary
The goal of this observational clinical trial is to learn if chest tomosynthesis is a potential alternative to computed tomography for the detection of lung cancer. It will also develop artificial intelligence tools to aid in the diagnosis of lung cancer on chest tomosynthesis images. Read more about this study
- Who is it for?
- Ages 30 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Chest X-ray Tomosynthesis
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2023to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing lung cancer screening CT or undergoing diagnostic chest CT for incidentally detected pulmonary nodules or lung cancer.
Who may be able to join
- undergoing lung cancer screening
- undergoing evaluation of suspicious pulmonary nodule
- newly diagnosed lung cancer
Who cannot join
- prior history of lung cancer treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Diego
San Diego, California, 92093
Alexander Cypro, MD, 858-246-2196, aidaresearch2023@gmail.com
About this study
Official title: Chest X-ray Tomosynthesis for Detection of Lung Cancer and Lung Disease
The goal of this observational clinical trial is to learn if chest tomosynthesis is a potential alternative to computed tomography for the detection of lung cancer. It will also develop artificial intelligence tools to aid in the diagnosis of lung cancer on chest tomosynthesis images. The main questions it aims to answer are:
- What is the accuracy of chest X-ray tomosynthesis in diagnosing lung cancer in a population of individuals undergoing lung cancer screening or evaluation of a suspicious lung nodule?
- Can artificial intelligence help us detect lung cancer on chest tomosynthesis images?
Read more
Researchers will compare chest tomosynthesis images to computed tomography scans for each participant to see how they compare in diagnosing lung cancer.
Participants will a chest tomosynthesis scan in addition to their routine clinical computed tomography scan.
Read the detailed description
Lung cancer remains the most common cause of cancer death in the United States for which low-dose CT has proven benefit for early detection and survival from lung cancer. However, adoption remains low. Furthermore, >95% of nodules detected on low-dose CT, especially those smaller than 6 mm, do not represent cancer. We have partnered to develop a novel chest x-ray tomosynthesis (CXRT) device with the hypothesis that this device might be an alternative to CT for detection of lung cancer. We seek to recruit a cohort of patients to undergo CXRT, composed of patients concurrently undergoing lung cancer screening CT and diagnostic CT for new lung cancer. We will determine the effectiveness of CXRT for detecting lung cancer in this population, evaluating its sensitivity and specificity for detecting cancer and lung nodules at multiple size thresholds in a multireader study. We will additionally develop artificial intelligence algorithms and evaluate their efficacy to further enhance cancer detection.
- Conditions
- Lung Cancer
- Being tested
- Chest X-ray Tomosynthesis
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest X-ray TomosynthesisDiagnostic test
Also called CXRT
An imaging device that uses X-rays projected from multiple angles to reconstruct a three-dimensional images of the chest
| Study group | Role | What they receive |
|---|---|---|
| Chest X-ray Tomosynthesis Participants | Participants who had a recent, routine clinical chest computed tomography scan for lung cancer screening or evaluation of nodule suspicious for lung cancer will undergo an additional chest X-ray tomosynthesis scan. Receives: Diagnostic Test: Chest X-ray Tomosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest X-ray tomosynthesis detection of lung cancer
Diagnostic accuracy of chest tomosynthesis in identifying biopsy-proven lung cancer
Measured: through 12/31/2026
Secondary outcomes (1)
Chest X-ray tomosynthesis detection of suspicious nodules
Diagnostic accuracy of chest tomosynthesis in identifying pulmonary nodules seen on chest CT at multiple minimum size thresholds: 6-mm, 8-mm, 10-mm
Measured: through 12/31/2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start2 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
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 California, San DiegoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- AIxSCAN, Inc.
- Responsible party
- Principal investigator, Albert Hsiao, University of California, San Diego
- Investigators
- Albert Hsiao, MD PhD, Principal investigator, UC San Diego, Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577883
- Sponsor's protocol ID
- 805210
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest X-ray Tomosynthesis for Detection of Lung Cancer and Lung Disease
- ClinicalTrials.gov ID
- NCT06577883
- Acronym / sponsor ID
- 805210
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- AIxSCAN, Inc.
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Aug 2024 (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 goal of this observational clinical trial is to learn if chest tomosynthesis is a potential alternative to computed tomography for the detection of lung cancer. It will also develop artificial intelligence tools to aid in the diagnosis of lung cancer on chest tomosynthesis images. The main questions it aims to answer are:
- What is the accuracy of chest X-ray tomosynthesis in diagnosing lung cancer in a population of individuals undergoing lung cancer screening or evaluation of a suspicious lung nodule?
- Can artificial intelligence help us detect lung cancer on chest tomosynthesis images?
Researchers will compare chest tomosynthesis images to computed tomography scans for each participant to see how they compare in diagnosing lung cancer.
Participants will a chest tomosynthesis scan in addition to their routine clinical computed tomography scan.
Detailed description
Lung cancer remains the most common cause of cancer death in the United States for which low-dose CT has proven benefit for early detection and survival from lung cancer. However, adoption remains low. Furthermore, >95% of nodules detected on low-dose CT, especially those smaller than 6 mm, do not represent cancer. We have partnered to develop a novel chest x-ray tomosynthesis (CXRT) device with the hypothesis that this device might be an alternative to CT for detection of lung cancer. We seek to recruit a cohort of patients to undergo CXRT, composed of patients concurrently undergoing lung cancer screening CT and diagnostic CT for new lung cancer. We will determine the effectiveness of CXRT for detecting lung cancer in this population, evaluating its sensitivity and specificity for detecting cancer and lung nodules at multiple size thresholds in a multireader study. We will additionally develop artificial intelligence algorithms and evaluate their efficacy to further enhance cancer detection.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chest X-ray Tomosynthesis Participants | – | Diagnostic Test: Chest X-ray TomosynthesisParticipants who had a recent, routine clinical chest computed tomography scan for lung cancer screening or evaluation of nodule suspicious for lung cancer will undergo an additional chest X-ray tomosynthesis scan. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing lung cancer screening CT or undergoing diagnostic chest CT for incidentally detected pulmonary nodules or lung cancer.
Key inclusion criteria (3 listed)
- undergoing lung cancer screening
- undergoing evaluation of suspicious pulmonary nodule
- newly diagnosed lung cancer
Key exclusion criteria (1 listed)
- prior history of lung cancer treatment
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 |
|---|---|---|
| Chest X-ray TomosynthesisAlso: CXRTAn imaging device that uses X-rays projected from multiple angles to reconstruct a three-dimensional images of the chest | Diagnostic test | Chest X-ray Tomosynthesis Participants |
Primary outcome
Chest X-ray tomosynthesis detection of lung cancer
Time frame: through 12/31/2026
Diagnostic accuracy of chest tomosynthesis in identifying biopsy-proven lung cancer
1 secondary outcome
Chest X-ray tomosynthesis detection of suspicious nodules
Time frame: through 12/31/2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- AIxScan, IncLink provided by the sponsor.
- 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.
Albert Hsiao, MD PhD principal investigator
UC San Diego, Department of Radiology
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 Cancer, run by University of California, San Diego 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 3 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: looking for participants now, as of the sponsor's last update on 29 Aug 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Cypro, MD (858-2462196, aidaresearch2023@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest X-ray tomosynthesis detection of lung cancer (time frame: through 12/31/2026). 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 29 Aug 2024.