HCC epatocellular carcinoma MedDRA version: 9.1 Level: HLT Classification code 10025577
Conditions
Interventions
Trade Name: SONOVUE
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Sulfur hexafluoride
Concentration unit: µl/ml microlitre(s)/millilitre
Concentration type:
Sponsors
BRACCO IMAGING
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult (age > or = 18 years) male or female; Providing written informed consent and willing to comply with protocol requirements; Confirmed diagnosis of advanced HCC either based on histology or based on AASDL criteria,as follows: -nodule 2 cm in maximum diameter: one imaging procedure (CE-CT or CE-MRI or CE-US) showing typical vascular pattern for HCC (contrast uptake in the arterial phase and washout in venous or late phases). Candidate to start sorafenib as monotherapy. At least one liver lesion, measurable according to RECIST criteria1 and evaluable by CE-US defined as: -Acoustic window sufficient for adequate US examination of the liver (all target HCC borders should be correctly visualized by B-mode and lesions adjacent to diaphragmatic border should be avoided). -Not previously treated -Diameter of 2 cm or more -Perfused area ≥ 50% of the total volume. At least 4 weeks since prior surgery/treatment with resolution of all acute toxic effects. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Has any clinically unstable cardiac condition prior to SonoVue administration such as: -evolving or ongoing myocardial infarction, -a history of acute myocardial infarction or percutaneous coronary interventions (PCI) within the previous 3 months, -worsening of typical angina at rest within the previous 7 days, -significant worsening of cardiac symptoms within the previous 7 days, -recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent deterioration of ECG, laboratory or clinical findings), -cardiac failure Class III/IV in accordance to the New York Heart Association , -severe cardiac rhythm disorders (ventricular tachycardia sustained and not sustained in combination with symptoms, flutter fibrillation, ventricular premature complexes occurring close to the preceding T-wave, multifocal complexes). Has respiratory failure or a known history of pulmonary hypertension. Known allergy to one or more of the ingredients of the investigational product. Known allergy to iodinated contrast agents and MRI contrast agents. Any other contraindication to one of the imaging examinations (US, CT or MRI) e.g. implants, claustrophobia, inadequate medical conditions etc. Any contraindication to sorafenib Has received an investigational compound within 30 days before admission into this study. Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations. Subject clinically unsuitable for the study as per Investigators judgment. Pregnant and lactating women. A pregnancy test (serum βHCG or urine stick) should be carried out within 24 hours prior to the administration of the investigational product to exclude pregnancy in women of child bearing potential.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether perfusion changes in one target HCC lesion assessed quantitatively by CE-US at week 2 and 4 of Sorafenib therapy can predict progression of disease at week 8 assessed by CE-MDCT/MRI, using standard RECIST criteria.;Secondary Objective: 1.To determine if perfusion changes in one target HCC lesion assessed quantitatively by CE-US at wk 2 and 4 of Sorafenib therapy: a)can predict progression of disease at wk 8 with CE-MDCT/MRI, using Llovet crit. b)correlate with OS c)correlate with TTP using RECIST/Llovet crit. d)can predict progression of the same lesion at wk 8 assessed with CE-MDCT/MRI,using Llovet crit. 5.In responder subj. at wk 8, to determine if perfusion changes in the target HCC lesion assessed quantitatively by CE-US at wk > 8 can identify earlier than CE-MDCT/MRI, HCC progression after wk 8. 6.To assess if progression of the target HCC lesion determined by the investigator based on qualitative evaluation of CE-US findings at wk 2 and 4 of Sorafenib therapy predict progression of disease at wk 8 assessed by CE-MDCT/MRI,using RECIST crit. 7.to compare diagnosis of qualitative evaluation of CE-US vs the best quantitative one for predict 1resistance to sorafenib 8. to assess safety of SonoVue;Primary end point(s): Perfusion changes will be evaluated by CE-US using a dedicated quantification software (SONOTUMOR) that allows calculation of several functional quantitative parameters including parameters related to blood volume (area under curve, perfusion index, maximum intensity, relative perfused area, perfused area) and parameters related to perfusion dynamics (mean transit time, time to peak, wash-in rate and wash-out rate, rise time). The primary quantitative parameter for evaluation of subject outcome based on CE-US cannot be selected a priori as no validated parameter and no validated response criteria are available yet. Thus, the predictiveness of the variations (% changes and absolute changes) of each of th | — |
Countries
Italy
Outcome results
None listed