Trial Search Results

Optimal Timing of BR55 CEUS of the Ovaries

This is an exploratory, single center, open label, prospective study of BR55 to determine the optimal phase of the menstrual cycle for performing BR55 CEUS of the target ovary in premenopausal women scheduled to undergo preventative surgery because of high familial/hereditary or genetic risk for ovarian cancer.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Bracco Diagnostics, Inc

Collaborator: National Institutes of Health (NIH)

Stanford Investigator(s):

Intervention(s):

  • Drug: BR55

Phase:

Phase 2

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mahima Goel
650-723-0371
Not Recruiting