TRASOUND (CEUS) IN UVEAL MELANOMA: EVALUATION OF RESPONSE TO GAMMA KNIFE RADIOSURGERY

Conditions: patients affected by uveal melanoma
MedDRA version: 14.1Level: PTClassification code 10061252Term: Intraocular melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: EUCTR2012-003164-50-IT

Lead Sponsor: OSPEDALE S. RAFFAELE DI MILANO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

-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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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 Outcome Measures

Name	Time	Method
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 ).<br>-Correlation between quantitative parameters’ variation and local and/or systemic disease recurrence. <br>-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