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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-001928-12-IT
Enrollment
Unknown
Registered
2007-06-14
Start date
2007-04-23
Completion date
Unknown
Last updated
2014-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal stromal tumor (GIST) MedDRA version: 9.1 Level: LLT Classification code 10061174 Term: Gastrointestinal neoplasm

Interventions

Trade Name: SONOVUE*1FL 8MCG+1SIR 5ML+ADAT Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: Sulfur hexafluoride Concentration unit: mg milligram(s) Concentrati

Sponsors

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026