Transabdominal Ultrasound With BR55 For Characterization Of Pancreatic Lesions

Study Overview

Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions

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.

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.

Pancreatic Ductal Adenocarcinoma

DRUG: BR55

BR55-110

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-03-02	Results First Submitted 2024-07-11	Last Update Submitted that met QC Criteria 2024-08-22
First Submitted that Met QC Criteria 2018-03-27	Results First Submitted that Met QC Criteria 2024-08-22	Last Update Posted (ACTUAL) 2024-08-23
First Posted (ACTUAL) 2018-04-03	Results First Posted 2024-08-23	Last Verified 2024-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 0.03mL/kg Dose Group A group of up to 8 subjects to receive a single dose of BR55 at 0.03mL/kg.	DRUG: BR55 A novel targeted ultrasound contrast agent
EXPERIMENTAL: 0.05mL/kg Dose Group A group of up to 8 subjects to receive a single dose of BR55 at 0.05mL/kg.	DRUG: BR55 A novel targeted ultrasound contrast agent
EXPERIMENTAL: 0.08mL/kg Dose Group A group of 8 subjects to receive a single dose of BR55 at 0.08mL/kg.	DRUG: BR55 A novel targeted ultrasound contrast agent

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 0.03mL/kg Dose Group

A group of up to 8 subjects to receive a single dose of BR55 at 0.03mL/kg.

DRUG: BR55

A novel targeted ultrasound contrast agent

EXPERIMENTAL: 0.05mL/kg Dose Group

A group of up to 8 subjects to receive a single dose of BR55 at 0.05mL/kg.

DRUG: BR55

A novel targeted ultrasound contrast agent

EXPERIMENTAL: 0.08mL/kg Dose Group

A group of 8 subjects to receive a single dose of BR55 at 0.08mL/kg.

DRUG: BR55

A novel targeted ultrasound contrast agent

Primary Outcome Measures	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).	Up to 24 hours post-dose on Day 1
2. Adverse Events	Number of participants who received the contrast agent and experienced an adverse event.	From the time of signing Informed Consent through 24 hours post-dose, up to a maximum of 11 days

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Institutes of Health (NIH)

Investigators

STUDY_DIRECTOR: Maria Luigia Storto, MD, Bracco Diagnostics, Inc

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record