Analysis of Lung Cancer Tissue With Spatial Frequency Domain Imaging
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spatial Frequency Domain Imaging.
- Who it may be relevant to
- Registry conditions: Lung Diseases, Cancer, Lung. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Spatial Frequency Domain Imaging
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.
Primary outcome measures
- Markers of native lung parenchyma [Time frame: May 7, 2023 to December 31, 2026]
Secondary outcome measures (1)
- Cancer identification [Time frame: May 7, 2023 to December 31, 2026]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- <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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of California, Irvine Medical Center — Orange
Identifiers
NCT: NCT06549088 · 2767