patients affected by uveal melanoma MedDRA version: 14.1 Level: PT Classification code 10061252 Term: Intraocular melanoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: SONOVUE*1FL 8MCG+1SIR 5ML+ADAT
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: esafluoruro di zolfo
Concentration unit: µl microlitre(s)
Concentrati
Sponsors
OSPEDALE S. RAFFAELE DI MILANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Adult subjects of >18 years of age; •Diagnosis of previously untreated Uveal Melanoma; •Tumour thickness >3 mm; •Eligibility for Gamma Knife Radiosurgery; •Adequate organ function (normal kidney and liver biochemical parameters, normal heart and bone marrow function); •Fertile females practicing adequate contraception; •ECOG score 0-1; •Life expectancy of at least 6 months; •Signed informed consent; Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: -Previous local treatment of Uveal Melanoma; -Tumour thickness < 3 mm; -Patients non eligible to brain-MRI pre-gamma knife due to anatomical or functional impairment; -Presence of distant metastasis; -Significant cardiovascular diseases requiring medical intervention or prior myocardial infarction within the last 2 years; -Simultaneous participation in another clinical trial, or participation in any clinical trial involving investigational drugs within 3 months from enrollment into the present study; -Any physical or psychological impediment in a patient that could lead the investigator to suspect his/her poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to determine if high-frequency CEUS using Sonovue, Bracco can be performed in the eye to visualize and quantify contrast enhancement in uveal melanoma before and after GKR.;Secondary Objective: -Identification of a correlation between response at A- and B- ultrasonography and at CEUS of the irradiated tumour. Evaluation of the possibility to assess CEUS quantitative parameters in future studies as predictors of tumour response to treatments.;Primary end point(s): Quantitative assessment of tumour vascularization in a specific R.O.I. (Region of Interest) pre and after tumour treatment with GKR by using different quantitative parameters: the main that will be investigated are TTP, RT, and PE (see the study procedures section for details).;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Correlation between variation of tumour size at A- and B- scan ultrasonography and of the quantitative parameters (TTP, RT, PE, AUC, WiPI, WiR, MTT ). -Correlation between quantitative parameters’ variation and local and/or systemic disease recurrence. -Monitoring of adverse events at the injection site, systemic allergic reactions, and other adverse events occurring within 30 minutes following Sonovue administration (Common Toxicity Criteria 4.0).;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Italy
Contacts
Public ContactRadiologia Diagnostica
IRCCS Ospedale San Raffaele
Outcome results
None listed