Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions

Conditions
-----------------
Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: BR55


Participation Criteria
=================
Eligibility Criteria
-----------------
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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Up to 24 subjects will be enrolled into 3 dose groups starting with the lowest dose group as follows: Dose group 0.03mL/kg, dose group 0.05mL/kg and dose group 0.08mL/kg/, with a maximum of 8 patients in each dose group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.03mL/kg Dose Group<br>A group of up to 8 subjects to receive a single dose of BR55 at 0.03mL/kg. | Drug: BR55<br>* A novel targeted ultrasound contrast agent<br>|
| Experimental: 0.05mL/kg Dose Group<br>A group of up to 8 subjects to receive a single dose of BR55 at 0.05mL/kg. | Drug: BR55<br>* A novel targeted ultrasound contrast agent<br>|
| Experimental: 0.08mL/kg Dose Group<br>A group of 8 subjects to receive a single dose of BR55 at 0.08mL/kg. | Drug: BR55<br>* A novel targeted ultrasound contrast agent<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Visual assessment of enhancement | BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement, weak enhancement, strong enhancement). | 1 Day | 
| 2. Adverse Events | Number of participants who received the contrast agent and experienced an adverse event. | 2 Days |