Patients with ovarian or breast cancer. MedDRA version: 14.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: BR55
Product Code: BR55
Pharmaceutical Form: Suspension for injection
Current Sponsor code: BR55
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25.4-
Sponsors
BRACCO IMAGING
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For all Participants: 1. Signed Informed Consent obtained. For ovarian Patients: 1. Post menopausal female; 2.No menstrual period for at least one year; 3. Age =18 years; 4. Established or suspected ovarian cancer diagnosis based on the following criteria: ovarian mass not greater than 10 cm in size / with suspected malignant solid component confirmed by diagnostic imaging / with or without extra-ovarian cancer spread including ascites and-or omental caking and-or peritoneal nodules/Scheduled to undergo ovarian surgery for primary cancer or ovarian mass within 30 days after enrollment. For breast Patients: 1. Female; 2. Age = 18 years; 3. Established or suspected breast cancer diagnosis based on diagnostic imaging (mammography, ultrasound, and/or MRI); 4. Scheduled to undergo primary breast cancer surgery or large core biopsy of the breast within 30 days after enrollment. 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 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
Exclusion criteria: Exclude a patient from this study if the subject does not fulfill the inclusion criteria, or if any of the following conditions are observed: Has a body weight =95 kg Has undergone prior systemic therapy for ovarian or breast cancer Has history of concurrent malignancy Has history of any clinically unstable cardiac condition including class III/IV congestive heart failure Has known right to left cardiac shunt, bidirectional or transient Has had any severe cardiac rhythm disorders within 7 days prior to enrolment Is known to suffer from stable angina pectoris and/or has suspected or proven coronary disease Has severe pulmonary hypertension (pulmonary artery pressure >90mmHg) or uncontrolled systemic hypertension and/or respiratory distress syndrome Has open and/or non-healing wounds in the chest, abdomen and pelvis Has other systemic vascular abnormalities associated with neovascularization, such as macular degeneration, that in the opinion of the investigator could significantly affect the ability to evaluate the effects of BR55. Is unable to comply with study protocol requirements for any reason. Is participating in a clinical trial or has participated in another trial with an investigational compound within the past 30 days prior to enrolment Has previously been enrolled in and completed this study Has any known allergy to one or more ingredients of the Investigational Product or to any other contrast media It is determined by the Investigator that the patient is clinically unsuitable for the study Ovarian Patients Additional exclusion criteria: Major surgery, including laparoscopic surgery, within 3 months prior to enrolment Breast Patients: Additional exclusion criteria: Pregnancy or breastfeeding. Exclude the possibility of pregnancy: o By testing on site at the institution (serum ßHCG) within 24 hours prior to the start of the IMP administration o By surgical history (e.g. tubal ligation or hysterectomy) Post menopausal within a minimum one year without menses History of significant acute or chronic breast abnormalities (e.g. infection or trauma) in the breast of interest. History of minor (e.g., fine-needle aspiration, needle core biopsy, vacuum-assisted core biopsy, cyst aspiration, or other similar procedures) or major (e.g., mastectomy, breast-conserving surgery, implants, open surgical biopsy, breast radiotherapy, or other similar procedures) procedures in the breast of interest.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess ultrasound imaging results with BR55 in the detection of cancer lesions in patients with ovarian cancer or ovarian mass or patient with breast cancer using histology as the truth standard for the presence/absence of malignant lesions.;Secondary Objective: To assess the binding of BR55 to VEGFR2 during contrast-enhanced ultrasound and compared with immunohistochemistry. To obtain safety data for BR55. To explore the optimum dose of BR55 in terms of the detection of cancer lesions in patients with ovarian cancer or ovarian mass or patient with breast cancer.;Primary end point(s): To assess ultrasound imaging results with BR55 in the detection of cancer lesions in patients with ovarian cancer or ovarian mass or patient with breast cancer using histology as the truth standard for the presence/absence of malignant lesions.;Timepoint(s) of evaluation of this end point: 72 hours after the administration of BR55. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess the binding of BR55 to VEGFR2 during contrast-enhanced ultrasound and compared with immunohistochemistry. To obtain safety data for BR55. To explore the optimum dose of BR55 in terms of the detection of cancer lesions in patients with ovarian cancer or ovarian mass or patient with breast cancer.;Timepoint(s) of evaluation of this end point: 72 hours after the administration of BR55. | — |
Countries
Italy
Contacts
Public ContactGlobal Medical & Regulatory Affairs
Bracco Imaging spa
Outcome results
None listed