Non-linear Multimodal Microendoscopy for Lung Cancer Pathology

December 3, 2024 updated by: University Health Network, Toronto

For this study the investigators are looking to do the following:

To characterize human lung lesions by nonlinear microscopy using ex vivo tissues.
To establish the first spectral/structural database for nonlinear optical microimaging of normal and abnormal lung tissue.

Study Overview

Status

Withdrawn

Conditions

Lung Cancer

Detailed Description

For this study the investigators are looking to do the following:

To characterize human lung lesions by nonlinear microscopy using ex vivo tissues. In particular, to investigate collagen content and ultrastructure with SHG (second harmonic generation) microscopy, to characterize cell and nuclear morphology and lipid vesicle content with THG (third harmonic generation) and CARS (coherent anti-Stokes Raman scattering) microscopy and to conduct spectroscopic and lifetime characterization of MPF (multiphoton fluorescence) signals in cancerous, benign, and normal tissues.
To establish the first spectral/structural database for nonlinear optical microimaging of normal and abnormal lung tissue, from which to generate diagnostic algorithms, both to optimize the operating parameters of planned nonlinear endoscopic imaging and to serve as the basis for nonlinear optical histopathology.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Lung Cancer Patients

Description

Inclusion Criteria:

Age 18 years or older.
Patients with confirmed or suspected lung cancer who require lobectomy as part of standard-of-care.

Exclusion Criteria:

Patients deemed on clinical grounds not to be medically fit for a lobectomy
Patients where there is a high clinical suspicion of lymphoma (to avoid mixing the data sets).
Patients unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Malignant Tissue sample
Benign Tissue sample
Normal Tissue Sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Nonlinear optical microscopy for cancerous tissue detection in human lung lesions Time Frame: Two years	Two years

Secondary Outcome Measures

Outcome Measure	Time Frame
The first spectral/structural database for nonlinear optical micro-imaging of normal and abnormal lung tissue Time Frame: Two Years	Two Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

Principal Investigator: Kazuhiro Yasufuku, MD, PhD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Actual)

December 3, 2024

Study Registration Dates

First Submitted

December 2, 2015

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimated)

March 4, 2016

Study Record Updates

Last Update Posted (Actual)

December 4, 2024

Last Update Submitted That Met QC Criteria