SPY-X: A Study to Assess the Feasibility of Using SPY Alone for Sentinel Node Localization for Melanoma or Breast Cancer (SPYX)
|ClinicalTrials.gov Identifier: NCT03294330|
Recruitment Status : Enrolling by invitation
First Posted : September 27, 2017
Last Update Posted : December 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sentinel Lymph Node Melanoma (Skin) Breast Cancer||Drug: IC-Green KIT||Phase 3|
From the subject's viewpoint, the course of events in this study will be no different than usual care and sentinel node biopsy. Subjects will have a dermal injection of technetium99 (tech99) at the melanoma tumor site prior to surgery (either the day before, or morning of surgery) or a subareolar injection if breast cancer. The surgeon will not look at the lymphoscintigraphy films, and the radiologist should not mark the skin. When the subject is in the operating room and appropriately sedated or anesthetized, tthey will receive a dermal injection of indocyanine green (ICG) 0.3-1.0 ml at the melanoma tumor site or subareola if breast cancer. Incision is made in the axilla or groin, and the SPY machine is positioned over the lymph node basin. Real-time lymphangiography (SPY) is used to identify sentinel nodes. Any fluorescent nodes should be resected and are considered sentinel nodes. The absolute fluorescence will be quantified for each sentinel node. Absolute fluorescence is calculated by the SPY machine.
After the sentinel lymphadenectomy is complete but prior to closing skin, the excised lymph nodes will be examined with the gamma probe (detects tech99 signal) to confirm that they are sentinel nodes. If the node does not have a signal with the gamma probe (but is fluorescent) it is still considered a sentinel node. The lymph node basin will also be examined with the gamma probe, to insure that no sentinel nodes are missed. If a gamma positive sentinel node is identified in the lymph node basin, it should be resected and imaged with SPY. If no sentinel nodes are able to be identified with fluorescent imaging, the gamma probe will be used as per usual practice. The surgeon should spend no more than 30 minutes using SPY to identify sentinel nodes. If after 30 minutes no sentinel node is found, the gamma probe should be used. The data collection form should be completed for each case.
The investigators intend to enroll at least 48 subjects. In order to insure that the data collected accurately represents the effectiveness of the SPY machine, each surgeon will be required to enroll at least 8 subjects into the study. Sentinel node biopsy is a routine surgical procedure, and all involved PIs are experienced in performing sentinel node biopsy. While fluorescence imaging intra-op is novel, the actual procedure itself is no different.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SPY-X: A Study to Assess the Feasibility of Using Real-time Fluorescence Lymphangiography Alone for Sentinel Node Localization in Patients With Melanoma or Breast Cancer|
|Actual Study Start Date :||October 11, 2017|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||December 2018|
U.S. FDA Resources
Experimental: Patients with Melanoma or Breast Cancer
The SPY machine used in conjunction with the IC-green kit will be used exclusively to identify sentinel nodes in patients diagnosed with Melanoma or Breast Cancer who are undergoing sentinel lymph node biopsy.
Drug: IC-Green KIT
fluorescence lymphangiography with the use of IC-Green
- number of sentinel nodes [ Time Frame: Immediate ]The number of sentinel nodes correctly identified with ICG and fluorescence imaging alone.
- Adverse events [ Time Frame: One week ]Any adverse events related to ICG and operative time for sentinel node biopsy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294330
|United States, Pennsylvania|
|PennState Health Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Wellspan York Hospital|
|York, Pennsylvania, United States, 17403|
|Principal Investigator:||Colette Pameijer, MD||Penn State Hershey Medical Center and College of Medicine|