Clinical trial · Interventional
Intravital Microscopy in Identifying Tumor Vessels in Patients With Stage IB-IIIC Melanoma Undergoing Sentinel Lymph Node Biopsy
Intravital Microscopy (IVM) During Sentinel Lymph Node (SLN) Biopsy for Melanoma
NCT02857374CI-TRIAL-00060002completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This pilot clinical trial studies intravital microscopy in identifying tumor vessels in patients with stage IB-IIIC melanoma undergoing sentinel lymph node biopsy. By examining sentinel lymph nodes through intravital microscopy before they are removed, doctors may learn specific information regarding how melanoma may spread to lymph nodes and other sites of the body.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IB Skin Melanoma | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
| Stage IIA Skin Melanoma | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
| Stage IIB Skin Melanoma | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
| Stage IIC Skin Melanoma | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
| Stage IIIA Skin Melanoma | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
| Stage IIIB Skin Melanoma | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
| Stage IIIC Skin Melanoma | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic Microscopy | Procedure | — | UNRESOLVED |
| Fluorescein Sodium Injection | Drug | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Sentinel Lymph Node Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (intravital microscopy)
- description
- Patients receive indocyanine green and fluorescein sodium injection IV and then undergo intravital microscopic observation over 15-20 minutes during standard of care sentinel node biopsy.
- interventionNames
- Procedure: Diagnostic Microscopy
- Drug: Fluorescein Sodium Injection
- Other: Laboratory Biomarker Analysis
- Procedure: Sentinel Lymph Node Biopsy
Primary outcomes (1)
- measure
- Feasibility of intravital microscopy in characterizing the microvasculature of the SLN in melanoma determined by successful visualization of at least 6 of 10 patients during Part I
- timeFrame
- Up to 3 weeks
- description
- The visualization method will be deemed successful in patients with tumor vessel identification, measurement of tumor vessel diameters, determining vessel density, and visualizing fluorescein/indocyanine green within the tumor vessels.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 * Melanoma tumor that meets indications for a groin SLN biopsy with a \>= 10% risk of having metastasis to the draining lymph node (i.e. stage IB to stage IIIC melanoma of the lower body below the umbilicus) * Participant must be eligible for a groin sentinel lymph node (SLN) biopsy * Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Sentinel lymph node is deemed inaccessible to microscopic observation during the operative procedure (i.e. sentinel node maps to a deep location or area outside of the groin) * Renal dysfunction as defined as creatinine clearance \< 70 mL/min by Cockroft-Gault equation * Any known allergy or prior reaction to fluorescein, indocyanine green, iodine, or shellfish * Unwilling or unable to follow protocol requirements * Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiogram \[EKG\], chest x-ray, or pulmonary function tests) * Any condition that excludes SLN biopsy as the standard of care (e.g. lymphadenectomy indicated)
References
Publications (0)
Data not yet available
No reference posted for this study.