Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06556680
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
EB-OCT Biopsy Guidance of Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Develop a High-resolution EB-OCT Platform to Visualize Guide Evaluate and Increase the Accuracy of Lung Cancer Diagnosis in Human Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our objective is to develop test and validate a clinically robust polarization-sensitive optical coherence tomography PS-OCT biopsy guidance and diagnosis platform that is compatible with standard bronchoscopy techniques
Detailed Description:
The goal of this study is to improve the unacceptably low diagnostic yield that is associated with low-risk bronchial biopsy The investigators propose to do this by developing and optimizing a novel high-resolution optical coherence tomography OCT platform that will provide superior endomicroscopy images for biopsy guidance and in vivo diagnosis of lung cancer OCT is a non-invasive imaging tool that rapidly generates high-resolution 10 µm cross-sectional images of biological tissues with penetration depths approaching 2-3 mm Polarization Sensitive OCT PS-OCT provides additional contrast to structural OCT by highlighting birefringent tissues such as collagen When coupled with appropriate catheter designs OCT can be used to conduct in vivo microscopy of tissue microstructure including the detection and diagnosis of cardiovascular gastrointestinal and lung pathology
The objective of this study is to develop test and validate a clinically robust PS-OCT biopsy guidance and diagnosis platform that is compatible with standard bronchoscopy techniques Specifically the investigators envision two clinical scenarios
Biopsy Guidance
Following the identification and gross localization of a nodule by low-dose computed tomography LDCT a low-risk transbronchial biopsy will be acquired for diagnosis Placement of the biopsy catheter will be performed using standard approaches including bronchoscopy electromagnetic navigation or robotic bronchoscopy The investigators will then conduct PS-OCT at the site to 1 confirm that the biopsy catheter is correctly positioned within the nodule and 2 ensure that diagnostic-quality tissue is obtained
OCT Diagnosis
For small isolated pulmonary nodules in vivo OCT imaging may open up the possibility of diagnosis and treatment within the same procedure For larger pulmonary nodules OCT images of the tissue microstructure may also be used to provide complementary information to pathologists and treating physicians to help make a clinical diagnosis particularly when biopsy samples are inadequate OCT can image a much larger volume of the tumor microenvironment than is possible with standard bronchial biopsy acquisition
The advantages of this new platform over existing OCT technology include novel endobronchial catheters that include metalenses in their design These catheters provide OCT images at significantly higher resolution over a greater depth of penetration than traditional OCT catheters Our OCT platform will also incorporate cutting-edge polarization-sensitive OCT PS-OCT imaging capabilities which investigators have demonstrated are necessary to distinguish between tumor and non-diagnostic tissues including tumor-associated scar PS-OCT is challenging to perform catheter-based imaging and extremely computationally expensive when it incorporates accurate catheter calibration and processing Our endobronchial OCT imaging system will provide real-time intra-procedural processing which is critical for OCT biopsy guidance and diagnosis
The objective of this study is to develop test and validate a clinically robust PS-OCT biopsy guidance and diagnosis platform that is compatible with standard bronchoscopy techniques Specifically the investigators envision two clinical scenarios
Biopsy Guidance
Following the identification and gross localization of a nodule by low-dose computed tomography LDCT a low-risk transbronchial biopsy will be acquired for diagnosis Placement of the biopsy catheter will be performed using standard approaches including bronchoscopy electromagnetic navigation or robotic bronchoscopy The investigators will then conduct PS-OCT at the site to 1 confirm that the biopsy catheter is correctly positioned within the nodule and 2 ensure that diagnostic-quality tissue is obtained
OCT Diagnosis
For small isolated pulmonary nodules in vivo OCT imaging may open up the possibility of diagnosis and treatment within the same procedure For larger pulmonary nodules OCT images of the tissue microstructure may also be used to provide complementary information to pathologists and treating physicians to help make a clinical diagnosis particularly when biopsy samples are inadequate OCT can image a much larger volume of the tumor microenvironment than is possible with standard bronchial biopsy acquisition
The advantages of this new platform over existing OCT technology include novel endobronchial catheters that include metalenses in their design These catheters provide OCT images at significantly higher resolution over a greater depth of penetration than traditional OCT catheters Our OCT platform will also incorporate cutting-edge polarization-sensitive OCT PS-OCT imaging capabilities which investigators have demonstrated are necessary to distinguish between tumor and non-diagnostic tissues including tumor-associated scar PS-OCT is challenging to perform catheter-based imaging and extremely computationally expensive when it incorporates accurate catheter calibration and processing Our endobronchial OCT imaging system will provide real-time intra-procedural processing which is critical for OCT biopsy guidance and diagnosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None