EB-OCT Biopsy Guidance of Lung Cancer

NCT06556680 | Not Yet Recruiting

• 2 other identifiers: 2024P0017145R01HL133664-05
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer

Keywords

Polarization Sensitive Optical Coherence Tomography; Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield of bronchial biopsy

  EB-OCT guided bronchial biopsy changes the diagnostic yield when compared to traditional biopsy.

  2 years

Secondary Outcomes (1)

• Determine the accuracy of OCT diagnosis of lung cancer in vivo by blinded reviewers.

  2 years

Study Arms (2)

Control Arm

NO INTERVENTION

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

OCT Imaging Arm

EXPERIMENTAL

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

Device: Optical coherence tomography

Interventions

Optical coherence tomography 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.

OCT Imaging Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Melissa J Suter, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa J Suter, PhD

CONTACT

617-724-7691; msuter@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Randomized control trial. patients will divided into two groups: 1) control group -Only regular bronchoscopy biopsy, and 2) OCT-guided imaging and biopsy.

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: August 16, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share