Non-linear Multimodal Microendoscopy for Lung Cancer Path... | NCT02699229

Studies
Non-linear Multimodal Microendoscopy for Lung Cancer Pathology

NCT02699229

Sponsor

University Health Network, Toronto

Status

Withdrawn

Last Update Posted

Dec 4, 2024Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Lung Cancer

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no particpants enrolled

Expanded Access Info

Start Date

Jan 11, 2024Actual

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 3, 2024Actual

First Submitted Date

Dec 2, 2015

First Submission Date that Met QC Criteria

Feb 29, 2016

First Posted Date

Mar 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2024

Last Update Posted Date

Dec 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Malignant		Tissue sample
Benign		Tissue sample
Normal		Tissue Sample

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Lung Cancer Patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kazuhiro Yasufuku, MD, PhD	University Health Network, Toronto	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided