Bronchial NIR Image-guided Resection
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/22/2019 |
| Start Date: | January 6, 2015 |
| End Date: | January 1, 2021 |
| Contact: | Yolonda Colson, MD, PhD |
| Email: | ycolson@partners.org |
| Phone: | 617-726-5200 |
Bronchial NIR Image-guided Resection, Mapping And Targeted Lymphadenectomy for Lung Lesions
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.
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.
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.
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.
Inclusion Criteria:
- Patients that have agreed to undergo video assisted thoracoscopic surgery or
thoracotomy for surgical resection as recommended by their thoracic surgeon.
- N2 lymph nodes negative on PET scan or (via mediastinoscopy, transthoracic, or
endobronchial ultrasound)
- 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.
We found this trial at
2
sites
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-5200
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75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-726-5200
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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