Lung CancerPhase 2NCT02090660
Technique for Localization of Pulmonary Nodules Using Spy Thoracoscope System
A Phase 2 study testing ICG Localization with Spy thoracoscope localization in people with Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- ICG Localization with Spy thoracoscope localization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Feb 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient scheduled for a VATS wedge lung resection using CT guided micro-coil lung implantation for the localization of the lung lesion.
Who cannot join
- Any patients with an allergy to iodine, shellfish, or cough mixture, betadine or other iodine contrast agents.
- Pregnant or potentially pregnant women.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network: Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
Official title: Feasibility of a Novel Minimally Invasive Technique for Localization of Pulmonary Nodules Using the Spy Thoracoscope System
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.
- Conditions
- Lung Cancer
- Being tested
- ICG Localization with Spy thoracoscope localization
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG Localization with Spy thoracoscope localizationOther
| Study group | Role | What they receive |
|---|---|---|
| VATS wedge lung resection | Experimental | Not described Receives: Other: ICG Localization with Spy thoracoscope localization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare incidence of Adverse Events (AE) occurrence due to ICG injection with micro-coil placement versus overall AE occurrence for micro-coil placement alone.
Measured: Within 4 hours of ICG injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Novadaq Technologies ULC, now a part of Stryker
- Responsible party
- Sponsor
- Investigators
- Kazuhiro Yasufuku, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090660
- Sponsor's protocol ID
- 12-5454
- Status last verified
- Feb 2018
- First submitted
- 10 Mar 2014
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Novel Minimally Invasive Technique for Localization of Pulmonary Nodules Using the Spy Thoracoscope System
- ClinicalTrials.gov ID
- NCT02090660
- Acronym / sponsor ID
- 12-5454
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Novadaq Technologies ULC, now a part of Stryker
- Study start
- Apr 2014
- Primary completion
- Feb 2016 (actual)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VATS wedge lung resection | Experimental | Other: ICG Localization with Spy thoracoscope localization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient scheduled for a VATS wedge lung resection using CT guided micro-coil lung implantation for the localization of the lung lesion.
Key exclusion criteria (2 listed)
- Any patients with an allergy to iodine, shellfish, or cough mixture, betadine or other iodine contrast agents.
- Pregnant or potentially pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICG Localization with Spy thoracoscope localization | Other | VATS wedge lung resection |
Primary outcome
Compare incidence of Adverse Events (AE) occurrence due to ICG injection with micro-coil placement versus overall AE occurrence for micro-coil placement alone.
Time frame: Within 4 hours of ICG injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazuhiro Yasufuku, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ICG Localization with Spy thoracoscope localization in people with Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare incidence of Adverse Events (AE) occurrence due to ICG injection with micro-coil placement versus overall AE occurrence for micro-coil placement alone. (time frame: Within 4 hours of ICG injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.