Clinical trial · Interventional
SPY-X: A Study to Assess the Feasibility of Using SPY Alone for Sentinel Node Localization for Melanoma or Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IC-Green KIT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with Melanoma or Breast Cancer
- description
- 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.
- interventionNames
- Drug: IC-Green KIT
Primary outcomes (1)
- measure
- Number of Participants Where the First, Second and Third Sentinel Nodes Localized With the Use of Fluorescence Imaging Alone
- timeFrame
- Intraoperative, up to 1 hour
- description
- The number of participants who had their first, second and third sentinel nodes correctly identified with ICG and fluorescence imaging alone, without the use of technetium99 and gamma probe. The number of sentinel nodes in any participant is determined by the patient's anatomy.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available