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Non-linear Multimodal Microendoscopy for Lung Cancer Pathology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02699229
Recruitment Status : Not yet recruiting
First Posted : March 4, 2016
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date December 2, 2015
First Posted Date March 4, 2016
Last Update Posted Date March 25, 2020
Estimated Study Start Date December 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 3, 2016)
Nonlinear optical microscopy for cancerous tissue detection in human lung lesions [ Time Frame: Two years ]
Original Primary Outcome Measures
 (submitted: February 29, 2016)
Nonlinear optical microscopy for cancerous tissue detection in human lung lesions [ Time Frame: Two years ]
1) 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.
Change History
Current Secondary Outcome Measures
 (submitted: March 3, 2016)
The first spectral/structural database for nonlinear optical micro-imaging of normal and abnormal lung tissue [ Time Frame: Two Years ]
Original Secondary Outcome Measures
 (submitted: February 29, 2016)
The first spectral/structural database for nonlinear optical micro-imaging of normal and abnormal lung tissue [ Time Frame: Two Years ]
We will 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-linear Multimodal Microendoscopy for Lung Cancer Pathology
Official Title Non-linear Multimodal Microendoscopy for Lung Cancer Pathology
Brief Summary

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

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

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

  1. 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.
  2. 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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Lung Cancer Patients
Condition Lung Cancer
Intervention Not Provided
Study Groups/Cohorts
  • Malignant
    Tissue sample
  • Benign
    Tissue sample
  • Normal
    Tissue Sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: February 29, 2016)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Alexandria Grindlay, BSc 416-634-7066 alexandria.grindlay@uhn.ca
Contact: Judy McConnell, BSc 416-581-7486 judy.mcconnell@uhn.ca
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02699229
Other Study ID Numbers 14-7485
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor University Health Network, Toronto
Collaborators Not Provided
Investigators
Principal Investigator: Kazuhiro Yasufuku, MD, PhD University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date March 2020