Lung DiseasesALCATSNCT06549088
Analysis of Lung Cancer Tissue With Spatial Frequency Domain Imaging
An observational study of Lung Diseases and Cancer, Lung, run by University of California, Irvine at 1 site in United States.
Trial summary
This study investigates if a new imaging device can detect different types of lung tissue using spatial frequency domain imaging (SFDI). Specifically, this study aims to detect lung nodules within normal lung tissue and determine if lung nodules are cancerous. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Cancer, Lung
- What is being tested?
- Spatial Frequency Domain Imaging
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2023to 31 Dec 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adults undergoing surgical resection of a suspected or confirmed lung mass.
Who may be able to join
- Greater than or equal to 18 years old
- Suspected or confirmed lung nodule on diagnostic imaging
- Undergoing lung resection using an open, endoscopic, or robotic approach
- Standard of care orders placed for a pathology assessment of resected lung tissue
- Adults undergoing lung resection for a lung mass
Who cannot join
- <18 years old
- Pregnant females and incarcerated individuals
- No standard of care orders to obtain a pathology assessment
- RUSH pathology order for resected lung tissue
- Any condition where the principal investigator determines to impact patient safety or quality of care
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
University of California, Irvine Medical Center
Orange, California, 92868
About this study
This study investigates if a new imaging device can detect different types of lung tissue using spatial frequency domain imaging (SFDI). Specifically, this study aims to detect lung nodules within normal lung tissue and determine if lung nodules are cancerous. Patients who have confirmed or suspected lung nodules and who are undergoing resection of those nodules will be recruited for the study. Study participants will undergo standard of care lung nodule resection in the operating room, and the resected specimen will be imaged using the SFDI device immediately after removal from the surgical field. The data captured from the SFDI images will then be compared to the pathology findings to identify optical properties of normal and cancerous lung tissue. Because the intervention is conducted on resected biospecimens, this study yields minimal risk to participants.
- Conditions
- Lung Diseases, Cancer, Lung
- Being tested
- Spatial Frequency Domain Imaging
- Medical subject headings
- Lung Diseases, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatial Frequency Domain ImagingDevice
Resected lung tissue will be removed from the surgical field and labeled with sutures per standard of care. The specimen will then be immediately analyzed using two SFDI devices in the operating room using sterile technique. Each specimen will be recorded up to three times to ensure at least one high fidelity recording is captured. The SFDI data will be analyzed and compared to the official pathology report from the electronic medical record.
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of native lung parenchyma
Use SFDI to identify markers of lung nodule vs native lung parenchyma
Measured: May 7, 2023 to December 31, 2026
Secondary outcomes (1)
Cancer identification
Distinguish cancer vs non-cancer in lung nodules with SFDI
Measured: May 7, 2023 to December 31, 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start7 Aug 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hari Keshava, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549088
- Sponsor's protocol ID
- 2767
- Acronym
- ALCATS
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 12 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 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Lung Cancer Tissue With Spatial Frequency Domain Imaging
- ClinicalTrials.gov ID
- NCT06549088
- Acronym / sponsor ID
- ALCATS / 2767
- Conditions
- Lung Diseases, Cancer, Lung
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 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.
This study investigates if a new imaging device can detect different types of lung tissue using spatial frequency domain imaging (SFDI). Specifically, this study aims to detect lung nodules within normal lung tissue and determine if lung nodules are cancerous. Patients who have confirmed or suspected lung nodules and who are undergoing resection of those nodules will be recruited for the study. Study participants will undergo standard of care lung nodule resection in the operating room, and the resected specimen will be imaged using the SFDI device immediately after removal from the surgical field. The data captured from the SFDI images will then be compared to the pathology findings to identify optical properties of normal and cancerous lung tissue. Because the intervention is conducted on resected biospecimens, this study yields minimal risk to participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adults undergoing surgical resection of a suspected or confirmed lung mass.
Key inclusion criteria (5 listed)
- Greater than or equal to 18 years old
- Suspected or confirmed lung nodule on diagnostic imaging
- Undergoing lung resection using an open, endoscopic, or robotic approach
- Standard of care orders placed for a pathology assessment of resected lung tissue
- Adults undergoing lung resection for a lung mass
Key exclusion criteria (5 listed)
- <18 years old
- Pregnant females and incarcerated individuals
- No standard of care orders to obtain a pathology assessment
- RUSH pathology order for resected lung tissue
- Any condition where the principal investigator determines to impact patient safety or quality of care
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 |
|---|---|---|
| Spatial Frequency Domain ImagingResected lung tissue will be removed from the surgical field and labeled with sutures per standard of care. The specimen will then be immediately analyzed using two SFDI devices in the operating room using sterile technique. Each specimen will be recorded up to three times to ensure at least one high fidelity recording is captured. The SFDI data will be analyzed and compared to the official pathology report from the electronic medical record. | Device | – |
Primary outcome
Markers of native lung parenchyma
Time frame: May 7, 2023 to December 31, 2026
Use SFDI to identify markers of lung nodule vs native lung parenchyma
1 secondary outcome
Cancer identification
Time frame: May 7, 2023 to December 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 12 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diseases and Cancer, Lung, run by University of California, Irvine 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 5 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 12 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?
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?
Markers of native lung parenchyma (time frame: May 7, 2023 to December 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 12 Aug 2024.