COMPLEX ADNEXAL MASS IN PELVIS Level: SOC Classification code 10029104
Conditions
Interventions
Trade Name: SonoVue®
Product Name: SONOVUE
Product Code: BR1
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Sulphur hexafluoride (SF6)
CAS Number: 2551-62-4
Sponsors
Bracco Imaging Spa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Pelvic masses with presumed presence of solid tissue (vascularized or not at Power Doppler examination) within the mass (unilocular-solid, multilocular-solid or solid adnexal masses) and multilocular masses with a number of septae greater than 10. The largest diameter must be less than 15 cm. •In case of multiple masses only one mass will be examined with SonoVue. The most complex one will be chosen; in case of similar ultrasound morphology the largest one or the one most easily accessible for CnTI will be selected. •18 years of age or older (pre- and postmenopausal patients, Hormone Replacement Therapy and contraceptive therapy users will be included) •Written informed consent given to participate in the study •Patients should undergo surgery within three months from the ultrasound examination 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: •Adnexal mass with sonographic features of dermoid cysts •Previous chemotherapy •Patients with any known allergy to one or more of the ingredients of the study agent •Patients with: evolving or ongoing myocardial infarction/ 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/ acute cardiac failure, class III/IV cardiac failure/ severe cardiac rhythm disorders. •Patients with any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data or of achieving the study objectives, Subjects previously entered in this study or having received an investigational drug within 30 days prior to admission to this study, •Medical condition, associated illness, or extenuating circumstances that make it highly unlikely that the 2 hour follow-up will be completed; •Pregnant or lactating female. Exclude the possibility of pregnancy: by testing on site at the institution (serum or urine ßHCG) within 24 hours prior to the start of study agent administration, by history (eg, tubal ligation or hysterectomy), post menopausal with a minimum 1 year without menses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of the study is to test prospectively the CnTI (Contrast Tuned Imaging) technology applied to an endovaginal probe after intravenous injection of the contrast agent SonoVue® in order: - to define the benign and malignant pattern of microcirculation in adnexal masses, and - to determine if this technique can contribute to a correct classification (benign or malignant) of adnexal masses with complex ultrasound morphology. The ultrasound diagnostic information obtained will be correlated with pathology. ;Secondary Objective: to obtain time-intensity curves on the microcirculation of adnexal masses with complex ultrasound morphology in order to define parameters which help in characterize the mass as benign or malignant. the ultrasound diagnostic information obtained will be correlated with pathology.;Primary end point(s): The primary endpoint of the study is, through the qualitative and quantitative assessment of haemodynamic behavior of SonoVue in the microcirculation of different adnexal masses and normal parenchyma to characterize the adnexal mass as benign or malignant in comparison with pathology. | — |
Countries
Italy, Sweden
Outcome results
None listed