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Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03486327
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : January 22, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

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.

Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Drug: BR55 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions
Actual Study Start Date : July 19, 2018
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021

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 :
  1. 1. Visual assessment of enhancement [ Time Frame: 1 Day ]
    BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement, weak enhancement, strong enhancement).

  2. 2. Adverse Events [ Time Frame: 2 Days ]
    Number of participants who received the contrast agent and experienced an adverse event.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486327


Contacts
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Contact: Julia Yureneva, MD 609-514-2554 julia.yureneva@diag.bracco.com

Locations
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United States, California
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94304
Contact: Mahima Goel    650-723-0371    mahimag@stanford.edu   
Contact: Walter Park, MD    (650)-723-4102    wgpark@stanford.edu   
Principal Investigator: Aya Kamaya, MD         
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94304
Contact: Aya Kamaya    650-723-8463    kamaya@stanford.edu   
Principal Investigator: Aya Kamaya         
Sponsors and Collaborators
Bracco Diagnostics, Inc
National Institutes of Health (NIH)
Investigators
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Study Director: Maria Luigia Storto, MD Bracco Diagnostics, Inc

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Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT03486327    
Other Study ID Numbers: BR55-110
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms