Clinical trial · Interventional
Sentinel Lymph Node (SLN) Biopsy for Conjunctival/Eyelid Melanoma
Sentinel Lymph Node Localization and Biopsy for Conjunctival and Eyelid Melanoma
NCT00386906CI-TRIAL-00089410completedPhase 1ClinicalTrials.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)
The goal of this clinical research study is to find the sentinel lymph node (SLN) (s) and biopsy it (them) to see if the patient has small or low volume metastatic disease that would otherwise have been missed.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Eye Disease | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentinel Lymph Node Mapping and Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Sentinel Lymph Node (SLN) Biopsy
- description
- Intraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor.
- interventionNames
- Procedure: Sentinel Lymph Node Mapping and Biopsy
Primary outcomes (1)
- measure
- Number of Patients with Sentinel Lymph Node (SLN) Positivity in Conjunctival/eyelid Melanomas
- timeFrame
- 3 months
- description
- The frequency of lymphatic drainage basins for bulbar versus palpebral conjunctiva and for nasal and the temporal quadrants estimated with 95% confidence intervals. The rate of identification of SLN evaluated with a confidence interval. The probability of positive SLN in primary conjunctival and eyelid melanoma estimated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participants must be 18 years of age or older. 2. Histologically documented malignant melanoma of the conjunctiva/eyelid greater than or equal to 1 millimeter in thickness, or those less than 1 mm thick that have evidence of ulceration, mitotic figures or are Clark IV. 3. A CXR, liver enzymes, and a head and neck computed tomography (CT) or magnetic resonance imaging (MRI) negative for evidence of metastasis. 4. Participant must have a negative ultrasound of regional lymph nodes (i.e., within 6 weeks of study enrollment). 5. Patient provided written informed consent. In the event that non-English speaking participants are eligible for this study, a short form (if applicable) or an ICD in their language, will be utilized and completed in accordance with the MDACC Policy for Consenting Non-English Speaking Participants. Exclusion Criteria: 1\) Pregnant or nursing females.
References
Publications (0)
Data not yet available
No reference posted for this study.