Status:
COMPLETED
SPY-X: A Study to Assess the Feasibility of Using SPY Alone for Sentinel Node Localization for Melanoma or Breast Cancer
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
Vassar Brothers Medical Center
Emory University
Conditions:
Sentinel Lymph Node
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to determine if fluorescence lymphangiography can be used alone to localize sentinel nodes in patients with melanoma or breast cancer. The hypothesis is that sentinel no...
Detailed Description
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 me...
Eligibility Criteria
Inclusion
- Patients with melanoma or breast cancer who meet criteria for and consent to sentinel node biopsy.The melanoma should be located on the upper extremity between and including the wrist and shoulder, or the lower extremity between and including the ankle and groin.
Exclusion
- Melanoma located on the trunk, head or neck. Patients with an allergy to indocyanine green or sodium iodide. Pregnant and nursing women. Patients who have had a prior sentinel node biopsy in the same nodal basin.
Key Trial Info
Start Date :
October 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2021
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03294330
Start Date
October 11 2017
End Date
November 2 2021
Last Update
January 12 2023
Active Locations (3)
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1
Emory University Hospital
Atlanta, Georgia, United States, 30322
2
Vassar Brothers Medical Center
Poughkeepsie, New York, United States, 12601
3
PennState Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033