Trial Search Results

Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions

This is an exploratory, single center, open label, parallel-dose, and prospective study of BR55 CEUS for characterization of solid pancreatic lesions in subjects with suspected PDAC using transabdominal US.

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 at least 18 years of age;

   - Has at least one solid pancreatic lesion;

   - Is scheduled to undergo surgical resection for suspected PDAC 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 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 IP 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 pancreatic cancer;

   - Has history of any 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 IP 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 pancreatic surgery (e.g., cyst removal);

   - Has acute pancreatic abnormalities (acute pancreatitis or trauma).

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

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