EB-OCT Biopsy Guidance of Lung Cancer

NCT ID: NCT06556680

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2027-01-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Control Arm

In the control arm, patients will only receive their regular scheduled bronchoscopy for biopsy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

OCT Imaging Arm

In the OCT-imaging arm, OCT images will be obtained and and used for biopsy guidance.

Group Type: EXPERIMENTAL

Optical coherence tomography

Intervention Type: DEVICE

In the OCT-guided biopsy arm, n=100 study subjects will be enrolled. The investigators will conduct biopsies and imaging using our newly developed OCT catheters and real-time image processing and display algorithms.

Interventions

Optical coherence tomography

In the OCT-guided biopsy arm, n=100 study subjects will be enrolled. The investigators will conduct biopsies and imaging using our newly developed OCT catheters and real-time image processing and display algorithms.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients undergoing elective lung biopsy for known or suspected malignancy in the lung
• Patients must be over the age of 21
• Patient must be able to give informed consent
• Negative pregnancy test for all females of childbearing potential who are sexually active and not using contraception, are seeking to become pregnant, or are nursing

Exclusion Criteria

• Patients who are pregnant
• The patient does not meet the requirements to undergo clinical bronchoscopy, as determined by the treating physician.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Melissa J. Suter

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melissa J Suter, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Central Contacts

Melissa J Suter, PhD

Role: CONTACT

msuter@mgh.harvard.edu

617-724-7691

Other Identifiers

5R01HL133664-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024P001714

Identifier Type: -

Identifier Source: org_study_id