Infrared Lymphangiography as a Method of Sentinel Node Identification (SPY-SN)
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|ClinicalTrials.gov Identifier: NCT02057393|
Recruitment Status : Completed
First Posted : February 7, 2014
Results First Posted : June 6, 2017
Last Update Posted : July 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Sentinel Node||Drug: Indocyanine green Drug: Technetium99 Drug: Methylene blue||Not Applicable|
Patients with melanoma of the trunk or extremities were prospectively enrolled in this trial. Patients with head and neck melanoma were excluded from this study based on our pilot experience. ICG is poorly visualized through muscle, and there seems to be high background uptake in the parotid gland; both of these features limit the utility of ICG and fluorescence imaging. All subjects had T1b or greater melanoma, and met current National Comprehensive Cancer Network (NCCN) guidelines for sentinel node biopsy. All subjects had injection of tech99 and lymphangiography prior to surgery, and injection of indocyanine green (ICG) and methylene blue dye (MB) in the operating room. We utilized methylene blue dye for all subjects due to poor availability of isosulfan blue for a period of time, and to maintain consistency in the trial. Up to 1ml of MB was injected, and 0.9ml ICG (2.5 mg/ml). The ICG and MB were injected into the dermis separately, after induction of anesthesia and prior to prepping the patient.
Each lymph node basin was examined with the gamma probe and imaged with the SPY Elite (Novadaq) prior to making skin incision, with assessment of the visibility of ICG through the skin (yes or no). Once incision was made, the basin was periodically imaged with SPY, or dissection was carried out with real time lymphangiography until the sentinel node was identified. The camera of the SPY machine is positioned over the basin, with the image projected onto a monitor. Similar to laparoscopy, the surgeon can watch the image and operate at the same time. Each sentinel node was assessed for the presence of each dye. A lymph node with any one of the dyes present was considered a sentinel node, and was resected. Fluorescence and blue dye were measured as yes or no, and not quantitated. Additional data collected includes demographic data, the dose of ICG and MB given, adverse effects from any dye, the total number of sentinel nodes identified and the number of malignant sentinel nodes. Pair-wise comparisons were made between the three dyes regarding the number of detected sentinel nodes, and the number of detected metastatic nodes.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Infrared Lymphangiography as a Method of Sentinel Node Identification|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||February 2016|
Experimental: Indocyanine Green
Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.
Drug: Indocyanine green
Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.
Other Name: IC-Green
Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.
Other Name: Technetium99 sulfur colloid
Drug: Methylene blue
Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye.
- Equivalence of ICG and Real Time Lymphangiography to technetium99 and Blue Dye in Localizing Sentinel Nodes [ Time Frame: 2 weeks ]The primary outcome measure is the accuracy of indocyanine green (ICG) and real time lymphangiography to identify sentinel nodes (SLN) in patients with melanoma, compared to tech99 and methylene blue. Tech99 is considered the standard, for comparison. Accuracy is being determined by the number of sentinel nodes that are identified with ICG, compared to tech99 or methylene blue.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057393
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Colette Pameijer, MD||Associate Professor of Surgery|