Bronchial NIR Image-guided Resection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ICG Intervention, Near Infrared Imaging.
- Who it may be relevant to
- Registry conditions: Sentinel Lymph Node. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Bronchial NIR Image-guided Resection, Mapping And Targeted Lymphadenectomy for Lung Lesions
Overview
This is a clinical trial to evaluate the use of peritumoral injection of near-infrared dye indocyanine green to identify lung lesions and sentinel lymph nodes. The primary purpose is to determine if the use of ICG injected via navigational bronchoscopy, CT-guided or transthoracic allows us to identify the first lymph node that drains from the tumor, and thus would be the most likely site for metastatic disease, and remove it for analysis to improve the ability to detect tumor in this node and to remove this additional site that potentially contains tumor cells. Using this intraoperative imaging technique, we aim to improve the identification of lung nodules for resection and the intraoperative identification of sentinel lymph nodes in the event that a lymphadenectomy is performed.
Detailed description
Patients enrolled in the study will undergo peritumoral injection of near-infrared dye indocyanine green around the lung lesion or within the adjacent segmental bronchus at the time of surgery. ICG injection will be carried out via navigational bronchoscopy, CT-guided or trans-thoracic ICG injection (dependent on lesion location) and ICG imaging of the sentinel lymph nodes will be undertaken using an NIR-enabled camera.
* This study is designed primarily to determine the safety and feasibility of intra-operative localization of thoracic lesions following ICG injection, and second, to include an assessment of the predictive value of sentinel lymph nodes relative to the disease status of the greater lymphadenectomy specimen as well as disease recurrence rates. * We are using a dose approximately 100 times lower than previously approved for injection in the blood. After a few minutes, the surgeon will look at these lymph nodes with near-infrared fluorescence and then remove any fluorescent and non-fluorescent lymph nodes near the tumor, as is standard for lung surgery. * The "filtered" near-infrared light causes the indocyanine green dye to fluoresce so that the surgeon can identify the lymph nodes most likely to contain tumor cells. If the lymph node is not found in the group of nodes usually removed, we will use the near-infrared light to look near the tumor for the sentinel lymph nodes and guide the surgeon so that the sentinel nodes can be removed and studied. The surgeon will then continue with the operation and remove the tumor. The lymph nodes are processed for special analysis tailored to finding metastasis in sentinel lymph nodes. * As is standard of care, patients will be monitored for evidence of recurrence by their surgeon. Recurrences will be recorded.
Interventions
- Drug ICG Intervention
Patients enrolled in the study will undergo injection of near infrared dye indocyanine green around the lung lesion or within the adjacent segmental bronchus at the time of surgery via navigational bronchoscopy, or if not amenable to navigational bronchoscopy injection, then injection will be carried out via a transthoracic approach through the incision or under CT-guidance. - Device Near Infrared Imaging
A near-infrared camera device will be used to detect indocyanine green following injection.
Primary outcome measures
- Incidence of treatment-emergent adverse events (safety and feasibility) of intraoperative NIR-image-guided localization of lung lesions using peritumoral ICG injection. [Time frame: 5 years]
Secondary outcome measures (2)
- Investigate whether SLNs can be identified using NIR-guidance following peritumoral ICG injection. [Time frame: 5 years]
- Assess if NIR image-guided SLN excision enhances detection of metastatic disease and whether the presence of untreated occult metastatic disease/mutational analysis of primary tumors/secondary sites of disease including SLNs are predictors of outcome [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Patients that have agreed to undergo video assisted thoracoscopic surgery or thoracotomy for surgical resection as recommended by their thoracic surgeon.
- 18 years of age or older
- Documented, signed, dated informed consent obtained prior to any study specific procedures being performed
Exclusion criteria
- Pregnant women are excluded and women of childbearing potential without a negative pregnancy test prior to study procedures. All patients with Iodine allergies will be excluded.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT03097575 · 2014P001436