AzTrials
AzTrials

Non-small Cell Lung CancerPhase 1ENB-RIGGSNCT02570958

ENB Robotic ICG Guided Surgery: A Novel Technique for Targeting Small Lung Tumors

A Phase 1 study testing Indocyanine Green in people with Non-small Cell Lung Cancer and Thoracic Surgery, run by St. Joseph's Healthcare Hamilton.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

Lung cancer is the leading cause of cancer deaths worldwide. However, if diagnosed at an early stage (tumor <2 cm), lung cancer is highly curable with a 5-year survival rate greater than 80% after surgical resection. Screening tests have made it easier to identify small lung tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer, Thoracic Surgery
What is being tested?
Indocyanine Green
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Oct 2017to Oct 2017
Phase
Phase 1
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

  • Age > 18 years
  • Peripheral lung tumour that is <2 cm in size on a CT scan
  • Fit to undergo thoracic surgery as assessed by the surgeon.

Who cannot join

  • Hypersensitivity or allergy to ICG, sodium iodide or iodine
  • Women who are currently pregnant or are breast feeding; or women of child bearing potential who are not currently taking adequate birth control.

About this study

Official title: Robotic ICG Guided Surgery (RIGGS) Using Electromagnetic Navigational Bronchoscopy (ENB): A Novel Technique for Targeting Small Lung Tumors

Lung cancer is the leading cause of cancer deaths worldwide. However, if diagnosed at an early stage (tumor <2 cm), lung cancer is highly curable with a 5-year survival rate greater than 80% after surgical resection. Screening tests have made it easier to identify small lung tumors. However, these tumors are often not visible to the naked eye, and surgeons cannot feel them, making them difficult to precisely locate and remove. For this reason, surgeons have become more reliant on image guided surgery for the removal of these tumors.

The standard of care for locating and removing small lung tumors is microcoil-guided video-assisted thoracoscopic surgery (VATS). This is a two-step procedure performed by two separate physicians.

Read more
  • First, patient is taken to radiology suite and radiologist inserts a microcoil near the lung tumor
  • Second (usually occurs a few hours later), patient is taken to operating room; a surgeon uses an x-ray arm to find the microcoil within the lung and remove it surgically.

A pathologist reviews the resected tissue to make sure that the tumor and the microcoil were both removed. Until this evaluation, the surgeon does not know whether the tumor has been removed or not. While this method is safe, it is time consuming, uses staff resources, and requires bulky equipment to complete.

In this study, we plan to develop and test a new method of identifying and removing small lung tumors. This procedure is called Electromagnetic Navigational Bronchoscopy (ENB) Robotic Indocyanine Green Guided Surgery (RIGGS) or ENB-RIGGS for a short name. The purpose of this study is to test the safety and reliability of the ENB-RIGGS surgery in the form of a pilot study.

ENB-RIGGS surgery is done in the operating room by a surgeon under general anesthetic. ENB-RIGGS begins by creating a 3-D GPS map of the lung which guides the surgeon directly to the tumor. A fluorescent green dye called indocyanine green is then injected into the tumor, and when viewed by the special robotic camera the tumour will fluoresce with a green hue allowing the surgeon to easily see the tumour. The surgeon then uses the robot to remove the tumor and surrounding tissue. The lung tissue specimen will be evaluated immediately by a pathologist.

Being tested
Indocyanine Green
Keywords
robotic surgery, indocyanine green, electromagnetic navigational bronchoscopy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indocyanine GreenDrug

    Also called IC-GREEN

    In the operating room ENB will be used to locate the targeted lung tumor. Once the tumor is located, the surgeon will advance a bronchoscope to the tumor, a needle will be passed through the bronchoscope, and the tumor will be injected with 100-150 micro liters of ICG solution at 0.125mg/mL concentration. The tumor is expected to fluoresce using the da Vinci Firefly robotic camera, giving off a bright green hue. Wedge resection of the fluorescent part of the lung will then be performed. The excised specimen will be sent for immediate pathologist analysis. If the tumor is found within the specimen, and the specimen margins are free of tumor cells, then the procedure will be completed. If the tumor cannot be targeted or visualized, or if the tumor is not found in the pathological specimen, or if the margins of the specimen contain tumor cells, then a formal anatomical lobectomy or segmental resection of the lung will be performed to ensure that the tumor is completely excised.

Study groups in NCT02570958
Study groupRoleWhat they receive
Indocyanine greenExperimentalNot described
Receives: Drug: Indocyanine Green

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety determined by the rates of adverse reactions to ICG dye, intra-operative adverse events, and post-operative complications as defined by the Ottawa Thoracic Morbidity and Mortality classification

    Measured: Post-operatively, an average of 2 years

  2. Reproducibility

    Reproducibility will be measured by the aggregate score on items 1-4 of the 6-item scale which include: targeting of tumor on ENB (advance a bronchoscope to the targeted tumor); injection of the tumour with ICG; detection of ICG fluorescence with near-infrared light; wedge resection. The reproducibility score for each procedure will be the sum of the first 4 items on the 6-item scale and can range between 0/4 to 4/4. The reproducibility rate will be defined as the percentage of patients who score 4/4 on the reproducibility scale.

    Measured: Post-operatively, an average of 2 years

  3. Oncological validity

    The oncological validity score for each procedure will be the sum of the last 2 items on the 6-item scale (ex-vivo localization of tumor; ex-vivo confirmation of tumour-free margins) and can range between 0/2 to 2/2. The oncological validity rate will be defined as the percentage of patients who score 2/2 on the oncological validity scale.

    Measured: Post-operatively, an average of 2 years

Secondary outcomes (3)

  1. Process Feasibility will be determined by recruitment rate (The proportion of patients enrolled in the study versus the number eligible, up to n=30)

    Measured: pre-operatively, an average of 2 years

  2. Management Feasibility will be determined by the percentage of cases for which ICG was successfully obtained from pharmacy and prepared for the ENB-RIGGS procedure

    Measured: pre-operatively, an average of 2 years

  3. Resource Feasibility will be determined by the sum of the dollar costs of the ENB-RIGGS materials and personnel required to perform the procedure, divided by the number of participants.

    Measured: pre-operatively, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2015 (estimated)
  2. Study startOct 2017 (estimated)
  3. Primary completionOct 2017 (estimated)
  4. Study completionOct 2017 (estimated)

Why it stopped: Funding was not received

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02570958
Sponsor's protocol ID
BFCRS-RP-002-1504-29
Acronym
ENB-RIGGS
Status last verified
Jun 2017
First submitted
6 Oct 2015
Last updated
5 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.

    PubMed 21714641

  • Finley RJ, Mayo JR, Grant K, Clifton JC, English J, Leo J, Lam S. Preoperative computed tomography-guided microcoil localization of small peripheral pulmonary nodules: a prospective randomized controlled trial. J Thorac Cardiovasc Surg. 2015 Jan;149(1):26-31. doi: 10.1016/j.jtcvs.2014.08.055. Epub 2014 Sep 16.

    PubMed 25293355

  • Hachey KJ, Colson YL. Current innovations in sentinel lymph node mapping for the staging and treatment of resectable lung cancer. Semin Thorac Cardiovasc Surg. 2014 Autumn;26(3):201-9. doi: 10.1053/j.semtcvs.2014.09.001. Epub 2014 Sep 16.

    PubMed 25527014

  • Okusanya OT, Holt D, Heitjan D, Deshpande C, Venegas O, Jiang J, Judy R, DeJesus E, Madajewski B, Oh K, Wang M, Albelda SM, Nie S, Singhal S. Intraoperative near-infrared imaging can identify pulmonary nodules. Ann Thorac Surg. 2014 Oct;98(4):1223-30. doi: 10.1016/j.athoracsur.2014.05.026. Epub 2014 Aug 5.

    PubMed 25106680

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Indocyanine Green in people with Non-small Cell Lung Cancer and Thoracic Surgery, run by St. Joseph's Healthcare Hamilton.

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 3 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: withdrawn, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was withdrawn before enrolling participants, so there are no results.

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?

Safety determined by the rates of adverse reactions to ICG dye, intra-operative adverse events, and post-operative complications as defined by the Ottawa Thoracic Morbidity and Mortality classification (time frame: Post-operatively, an average of 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02570958, which also lists 4 linked publications.

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 5 Jun 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in