At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 35 enrolled
Drug / intervention
IC-Green KITdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating IC-Green KIT for Sentinel Lymph Node and 2 related conditions. Completed, enrolled 35 participants across 3 sites.
Detailed 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 nodes can be identified using only indocyanine green (ICG) and fluorescence lymphangiography, without the need for technetium99 and a gamma probe.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSentinel Lymph Node, Melanoma (Skin), Breast Cancer
CountriesUnited States
CollaboratorsVassar Brothers Medical Center, Emory University
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 2017
Enrollment StartOct 2017
Primary CompletionSep 2021
Study CompletionNov 2021
TodayJul 2026
First PostedSep 27, 2017
Enrollment StartOct 11, 2017
Primary CompletionSep 17, 2021
Study CompletionNov 2, 2021
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.8 years ago
Interventions
IC-Green KITdrug
fluorescence lymphangiography with the use of IC-Green