Contrast enhanced ultrasonography effectiveness in early evaluating of the response to the Sunitinib in the patients with advanced GIST. A pilot study - ND

• Conditions: Gastrointestinal stromal tumor (GIST); MedDRA version: 9.1Level: LLTClassification code 10061174Term: Gastrointestinal neoplasm

• Registration Number: EUCTR2007-001928-12-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-14
• Last Update Posted: 24 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Male or female aged at least 18 years

-Pathologic diagnosis of GIST

-Hepatic and intra-abdominal metastasis don?t resectable

-Diameter lesions > 5 mm ( at least one lesion)

-Treatment with Sutinib after progression or Imatinib intolerance

-Patient acceptance of the trial and pertinent signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients with contraindications to use of Sonovue

-IMA in the last six months

-Adult respiratory distress syndrome

-Non patient acceptance of the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Study target consists in demonstrating the effectiveness of the CEUS in early evaluating of the response to the Sunitinib in the patients with advanced GIST by changes of vascular pattern (angiogenesis)of the lesions. The response in CEUS will be validated vs CT and FDG/PET.;Secondary Objective: none declared in protocol;Primary end point(s): effectiveness of the CEUS in early evaluating of the response to the Sunitinib in the patients with advanced GIST by changes of vascular pattern (angiogenesis)of the lesions. The response in CEUS will be validated vs CT and FDG/PET.