Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions

August 22, 2024 updated by: Bracco Diagnostics, Inc
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

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

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University Medical Center

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
1. Visual Assessment of Enhancement
Time Frame: 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).
Up to 24 hours post-dose on Day 1
2. Adverse Events
Time Frame: 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.
From the time of signing Informed Consent through 24 hours post-dose, up to a maximum of 11 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bracco Diagnostics, Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Maria Luigia Storto, MD, Bracco Diagnostics, Inc

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 13, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BR55-110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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