Clinical trial · Interventional
Sonazoid-Enhanced Ultrasound in Detecting Sentinel Lymph Node in Patients With Cutaneous Melanoma
Pilot Translational Study of Sonazoid-Enhanced Ultrasonography for Sentinel Lymph Node Mapping in Cutaneous Melanoma
NCT02968680CI-TRIAL-00044311terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient accrual
Summary
Brief summary (as posted)
This pilot phase I trial studies how well sonazoid-enhanced ultrasound works in detecting sentinel lymph node in patients with cutaneous melanoma. Sonazoid is a contrast agent that may make it easier to see if the tumor cells have spread to the sentinel lymph node using an ultrasound.
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 |
|---|---|---|---|
| Cutaneous Melanoma | Cutaneous Melanoma | ONTOLOGY_EXACT | 0.98 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentinel Lymph Node Biopsy | Procedure | — | UNRESOLVED |
| Sonazoid | Drug | — | UNRESOLVED |
| Ultrasonography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (sonazoid, ultrasound imaging, SLNB)
- description
- Patients receive sonazoid ID and undergo ultrasound imaging. Patients also undergo standard of care SLNB.
- interventionNames
- Procedure: Sentinel Lymph Node Biopsy
- Device: Ultrasonography
- Drug: Sonazoid
Primary outcomes (1)
- measure
- Percent of patients with SLN identified by sonazoid-US alone or both sonazoid-US and conventional methods
- timeFrame
- Up to 1 year
- description
- Analyzed using descriptive comparison.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Cutaneous melanoma with Breslow depth \> 1 mm or melanoma Breslow depth of 0.76 - 1.00 mm in setting of ulceration, extensive regression * Mitotic rate \>= 1/mm\^2 * Presence of angiolymphatic invasion * Deep positive margin * No known allergies to contrast material Exclusion Criteria: * Pregnant or nursing * Patients with known cardiac shunt * Patients with class II heart failure or worse, per New York Heart Association (NYHA) classification * Patients who have experienced an acute coronary syndrome or angina in the past 6 months * Patients who have undergone coronary artery bypass grafting (CABG) or coronary stenting in the past 3 years * Patients with evidence of moderate or severe cardiac valvular disease on echocardiogram * Patients with evidence of moderate or severe pulmonary hypertension on echocardiogram * Patients with stage II chronic obstructive pulmonary disease (COPD) or worse, per Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification * Patients with hypersensitivity to sonazoid or one of its components * Patients with hypersensitivity to egg or egg products, because sonazoid contains a chicken egg-derived surfactant (hydrogenated egg phosphatidylserine sodium) * Patients who cannot consent for themselves
References
Publications (0)
Data not yet available
No reference posted for this study.