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 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

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mahima Goel
650.723.0371
Recruiting