Trial Search Results

BR55 in Characterization of Ovarian Lesions

This is an exploratory phase II,open label, prospective study of BR55 CEUS for characterization of ovarian lesions in subjects with suspected 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 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.

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