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Near-Infrared Fluorescence Guided Robotic Pulmonary Segmentectomy for Early Stage Lung Cancer

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv15
  2. Notable Primary completion date: Oct 2024 to Oct 2026
    • Study completion date: Dec 2024 to Dec 2026
    v14
  3. Minor Re-verified, no change to tracked fieldsv13
  4. Notable Primary completion date: Oct 2022 to Oct 2024
    • Study completion date: Dec 2022 to Dec 2024
    v12
  5. Minor Re-verified, no change to tracked fieldsv11
Show 9 earlier versionsHide 9 earlier versions
  1. Minor Enrollment target: 175 to 250v10
  2. Notable Enrollment target: 30 to 175
    • Secondary endpoints: 13 to 14
    • Collaborators shortened, about 3 words
    v9
  3. Minor Re-verified, no change to tracked fieldsv8
  4. Notable Primary completion date: Oct 2017 to Oct 2022
    • Study completion date: Dec 2017 to Dec 2022
    v7
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v6
  6. Minor Primary completion date: Sep 2017 to Oct 2017
    • Study completion date: Nov 2017 to Dec 2017
    • Start date: Sep 2016 to Oct 2016
    v5
  7. Notable Primary completion date: Jun 2016 to Sep 2017
    • Start date: Jun 2016 to Sep 2016
    • Study completion date: Sep 2016 to Nov 2017
    v4
  8. Notable Start date: Jan 2016 to Jun 2016
    • Primary completion date: Jan 2016 to Jun 2016
    • Study completion date: Feb 2016 to Sep 2016
    v3
  9. Notable Start date: Nov 2015 to Jan 2016v2 Show 4 more changesShow less
    • Primary completion date: Nov 2015 to Jan 2016
    • Study completion date: Jan 2016 to Feb 2016
    • Secondary endpoints: details revised at 13 of 13 entries
    • Study title expanded, about 1 word
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Lungs are made up of individual lobes. When a lung cancer tumour is detected in one of these lobes, surgeons typically perform a Lobectomy. A Lobectomy is the surgery most commonly done to treat early-stage lung cancer and requires removal of an entire lobe of the lung, which removes a large amount of lung tissue For patients with small tumours saving as much healthy lung tissue as possible is important. Each lobe of the lung has smaller sections called segments. When a lung cancer is in one of these segments, it is possible to remove that segment, without removing the entire lobe. This surgery is called a segmentectomy. Compared to a lobectomy, a segmentectomy saves a larger amount of healthy lung tissue. With the advances in screening technology for lung cancer tumours, an increasing amount of very small lung cancer tumours are being found, and the demand for segmentectomy is increasing. A segmentectomy is a hard surgery to perform robotically because it is difficult to view the tissue lines that separate each segment within the lobe. As a result, it is difficult for the surgeon to see exactly which pieces of tissue should be removed. Because of these challenges, many patients having robotic surgery will have a lobectomy, even if a full lobectomy is not needed. Near-Infrared Fluorescence (NIF) using indocyanine green (ICG) fluorescent dye is a recent advancement in the robotic platform of robotic surgery. The surgeon will view the CT scan to determine which segment the tumour is located in. Once identified, the surgeon will isolate the segment by cutting off the blood supply to that segment. Then ICG will be injected into a vein. It is expected that the entire lung, except the isolated segment, which will remain 'dark' as it was isolated from blood supply, will fluoresce, giving off a green hue when viewed with the da Vinci Firefly camera. The surgeon will identify 'dark' segment, and will remove it. A pathologist will examine the excised tissue to ensure that the tumour was removed in its entirety. Once confirmed, the surgeon will end the procedure. If the pathologist determines that the segment removed did not contain the entire tumour, then the surgeon will perform a routine lobectomy. This ensures patient safety and confirms that all participants will have the entire tumour removed from their lung.
Trial Details
NCT Number NCT02570815
Lead Sponsor St. Joseph's Healthcare Hamilton
Conditions
(from sponsor)
Non-small Cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov