NCT02090660

Brief Summary

This study will determine the feasibility of the novel Indocyanine Green (ICG) fluorescence localization technique with a Laser fluorescence thoracoscope system. The primary objective of this study is to prove the validity and safety of our novel fluorescent localization method with utilized ICG and novel near infra-red fluorescence videoscope system.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2 lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

1.8 years

First QC Date

March 10, 2014

Last Update Submit

February 22, 2018

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Compare incidence of Adverse Events (AE) occurrence due to ICG injection with micro-coil placement versus overall AE occurrence for micro-coil placement alone.

    Within 4 hours of ICG injection

Study Arms (1)

VATS wedge lung resection

EXPERIMENTAL
Other: ICG Localization with Spy thoracoscope localization

Interventions

ICG Localization with Spy thoracoscope localizationOTHER
VATS wedge lung resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient scheduled for a VATS wedge lung resection using CT guided micro-coil lung implantation for the localization of the lung lesion.

You may not qualify if:

  • Any patients with an allergy to iodine, shellfish, or cough mixture, betadine or other iodine contrast agents.
  • Pregnant or potentially pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network: Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Kazuhiro Yasufuku, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 18, 2014

Study Start

April 1, 2014

Primary Completion

February 1, 2016

Last Updated

February 26, 2018

Record last verified: 2018-02

Locations

CA(1)