Back to results

Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions

Primary Purpose

Pancreatic Ductal Adenocarcinoma

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

BR55

About this trial

This is an interventional diagnostic trial for Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Stanford University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

0.03mL/kg Dose Group

0.05mL/kg Dose Group

0.08mL/kg Dose Group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

1. Visual assessment of enhancement

BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement, weak enhancement, strong enhancement).

2. Adverse Events

Number of participants who received the contrast agent and experienced an adverse event.

Secondary Outcome Measures

Full Information

NCT ID

NCT03486327

First Posted

March 2, 2018

Last Updated

August 8, 2023

Sponsor

Bracco Diagnostics, Inc

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT03486327

Brief Title

Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions

Official Title

Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 19, 2018 (Actual)

Primary Completion Date

October 31, 2021 (Actual)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bracco Diagnostics, Inc

Collaborators

National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Ductal Adenocarcinoma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Sequential Assignment

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)

Allocation

Non-Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.03mL/kg Dose Group

Arm Type

Experimental

Arm Description

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

Arm Title

0.05mL/kg Dose Group

Arm Type

Experimental

Arm Description

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

Arm Title

0.08mL/kg Dose Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

BR55

Intervention Description

A novel targeted ultrasound contrast agent

Primary Outcome Measure Information:

Title

1. Visual assessment of enhancement

Description

BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement, weak enhancement, strong enhancement).

Time Frame

1 Day

Title

2. Adverse Events

Description

Number of participants who received the contrast agent and experienced an adverse event.

Time Frame

2 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Luigia Storto, MD

Organizational Affiliation

Bracco Diagnostics, Inc

Official's Role

Study Director

Facility Information:

Facility Name

Stanford University Medical Center

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions

We'll reach out to this number within 24 hrs