BR55 in Characterization of Ovarian Lesions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03493464|
Recruitment Status : Completed
First Posted : April 10, 2018
Last Update Posted : March 2, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: BR55||Phase 2|
A total of sixty (60) subjects scheduled to undergo salpingo-oophorectomy within 30 days of BR55 CEUS examination will be enrolled to obtain approximately 30 subjects with benign ovarian lesions and 30 with malignant ovarian lesions based on the TS.
The first 10 subjects will receive BR55 at a dose of 0.03 mL/kg. Assuming these first 10 subjects will show technically adequate images, subsequent subjects enrolled in the study will continue to receive 0.03 mL/kg dose of BR55; otherwise, subjects will be switched to a 0.05 mL/kg dose of BR55.
The final cancer diagnosis will be obtained for all subjects by histopathology.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||A total of sixty (60) subjects will be evaluated in the study. The first 10 subjects enrolled in the study will receive BR55 at a dose of 0.03 mL/kg. Assuming these first 10 subjects will show technically adequate images, subsequent subjects enrolled in the study will continue to receive 0.03 mL/kg dose of BR55; otherwise, subjects will be switched to a 0.05 mL/kg dose of BR55.|
|Masking:||None (Open Label)|
|Official Title:||BR55 Contrast Enhanced Ultrasound (CEUS) in Characterization of Ovarian Lesions|
|Actual Study Start Date :||December 13, 2018|
|Actual Primary Completion Date :||August 1, 2021|
|Actual Study Completion Date :||October 1, 2021|
Subjects will receive a single dose of BR55 at 0.03 mL/kg or 0.05 mL/kg.
A novel targeted ultrasound contrast agent
- Visual assessment of enhancement [ Time Frame: 1 Day ]BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement, weak enhancement, strong enhancement).
- Adverse Events [ Time Frame: 2 Days ]Number of participants who received the contrast agent and experienced an adverse event.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||Female only|
|Accepts Healthy Volunteers:||No|
Inclusion Criteria: Enroll a subject if he/she meets the following inclusion criteria:
- Is at least 18 years of age;
- Has an ovarian lesion that is visible and assessable with trans-vaginal ultrasound;
- Is scheduled to undergo salpingo-oophorectomy for suspected ovarian cancer not earlier than 24 hours and not later than 30 days following BR55 administration;
- Provides written Informed Consent and is willing to comply with protocol requirements.
Exclusion Criteria: Exclude a subject 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),
- by post-menopausal status with a minimum 1 year without menses;
- 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, such as macular degeneration, 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493464
|United States, California|
|Stanford University Medical Center|
|Palo Alto, California, United States, 94304|
|Study Director:||Maria Luigia Storto, MD||Bracco Diagnostics, Inc|
|Responsible Party:||Bracco Diagnostics, Inc|
|Other Study ID Numbers:||
|First Posted:||April 10, 2018 Key Record Dates|
|Last Update Posted:||March 2, 2022|
|Last Verified:||January 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|