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Clinical Trials/NCT04248153
NCT04248153TerminatedPhase 2

An Exploratory Study to Determine the Optimal Timing of BR55 Contrast Enhanced Ultrasound (CEUS) of the Ovaries in Pre-menopausal Women

Bracco Diagnostics, Inc1 site in 1 country3 target enrollmentStarted: October 14, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
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

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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