Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions

Phase 2

Terminated

Conditions: Pancreatic Ductal Adenocarcinoma

Interventions: Drug: BR55

Registration Number: NCT03486327

Lead Sponsor: Bracco Diagnostics, Inc

Brief Summary: This is an exploratory, single center, open label, parallel-dose, and prospective study of BR55 contrast-enhanced ultrasonography (CEUS) for characterization of solid pancreatic lesions in subjects with suspected pancreatic ductal adenocarcinoma (PDAC) using transabdominal US.

Detailed Description: Approximately twenty-four (24) subjects with suspected PDAC and scheduled to undergo surgical resection within 30 days (but not before 24 hours) after the transabdominal BR55 CEUS examination will be enrolled into 3 dose groups, 0.03, 0.05, and 0.08 mL/kg, with a maximum of 8 patients in each dose group.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 4

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 investigational product (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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
0.03mL/kg Dose Group	BR55	A group of up to 8 subjects to receive a single dose of BR55 at 0.03mL/kg.
0.05mL/kg Dose Group	BR55	A group of up to 8 subjects to receive a single dose of BR55 at 0.05mL/kg.
0.08mL/kg Dose Group	BR55	A group of 8 subjects to receive a single dose of BR55 at 0.08mL/kg.

Primary Outcome Measures

Name	Time	Method
1. Visual Assessment of Enhancement	Up to 24 hours post-dose on Day 1	BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement, weak enhancement, strong enhancement).
2. Adverse Events	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 Outcome Measures