NCT04248153TerminatedPhase 2
An Exploratory Study to Determine the Optimal Timing of BR55 Contrast Enhanced Ultrasound (CEUS) of the Ovaries in Pre-menopausal Women
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Bracco Diagnostics, Inc
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Adverse Events
Study Overview
Brief Summary
This is an exploratory, single center, open label, prospective study of BR55 to determine the optimal phase of the menstrual cycle for performing BR55 contrast-enhanced ultrasonography (CEUS) of the target ovary in premenopausal women scheduled to undergo preventative surgery because of high familial/hereditary or genetic risk for ovarian cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Enroll a subject in this study if the subject meets the following inclusion criteria:
- •Is a female subject of at least 18 years of age;
- •Is premenopausal;
- •Is scheduled to undergo preventative salpingo-oophorectomy for high risk of ovarian cancer not earlier than 24 hours and not later than 5 days following the second BR55 CEUS examination;
- •Provides written Informed Consent and is willing to comply with protocol requirements.
Exclusion Criteria
- •Exclude a subject from this study if the subject does not fulfill the inclusion criteria, or if any of the following conditions are observed:
- •Is a pregnant or lactating female. Exclude the possibility of pregnancy:
- •by testing on site at the institution (serum βHCG) within 24 hours prior to the start of investigational product administration,
- •by surgical history (e.g., tubal ligation or hysterectomy),
- •Has undergone prior systemic therapy for ovarian cancer;
- •Has history of concurrent malignancy;
- •Has history of any clinically unstable cardiac condition including class III/IV congestive heart failure;
- •Has had any severe cardiac rhythm disorders within 7 days prior to enrolment;
- •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 that in the opinion of the investigator could significantly affect the ability to evaluate the effects of BR55;
- •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 of the ingredients of the Investigational Product or to any other contrast media;
- •Is determined by the Investigator that the subject is clinically unsuitable for the study;
- •Has had major surgery, including laparoscopic surgery, within 3 months prior to enrolment;
- •Has history of surgery to the ovaries or pelvic inflammatory disease.
Arms & Interventions
Group A
Experimental
BR55 will be performed in the early follicular phase first and in the late follicular phase thereafter.
Intervention: BR55 (Drug)
Group B
Experimental
BR55 will be performed in the late follicular phase first and in the early follicular phase thereafter.
Intervention: BR55 (Drug)
Outcomes
Primary Outcomes
Adverse Events
Time Frame: From the time of signing Informed Consent through 24 hours post-dose, up to a maximum of 11 days
Number of participants who received the contrast agent and experienced an adverse event.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Not yet recruiting
Not Applicable
The exploratory study to determine the optimal initial dose of tyrosine kinase inhibitors including combination immunotherapy in individual patients with advanced renal cell carcinomarenal cell carcinomaJPRN-UMIN000040923Department of Urology, Graduate School of Medicine, Yamaguchi University100
Active, not recruiting
Phase 1
EPOC B - An exploratory study to investigate the optimal scheduling of chemotherapy in patients with operable colorectal liver metastases.Colorectal cancer with resectable liver metastasesMedDRA version: 14.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-003052-40-GBSouthampton University Hospital NHS Trust78
Completed
Not Applicable
Investigating the optimal scheduling of chemotherapy in patients with colorectal and liver cancerDisease: LiverMalignant neoplasm of rectosigmoid junctionCancerColorectal CancerISRCTN32401805Southampton University Hospitals NHS Trust (UK)78
Completed
Not Applicable
Micro-Technique SamplingDermatitisNCT03242577Kimberly-Clark Corporation10
Completed
Not Applicable
Clinical Study on the Efficiency of Three Different Attachment Systems for Implant-supported Mandibular OverdentureMANDIBLEATROPHYC EDENTULOUS JAWNCT01034930Concordia Dent Srl69