Sonazoid-Enhanced Ultrasound in Detecting Sentinel Lymph Node in Patients With Cutaneous Melanoma
Stopped early · Phase 1
Conditions studied: Cutaneous Melanoma, Melanoma
In brief
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.
Key facts
- Study ID
- NCT02968680
- Run by
- University of Southern California
- People needed
- 5
- Starts
- 2017-04-26
- Expected to finish
- 2020-01-09
- Last updated by the study team
- 2020-03-30
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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