Clinical trial NCT03486327: Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions
Official title: Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreatic Ductal Adenocarcinoma
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
First posted: 2018-04-03
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

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 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).

Primary outcomes:
measure: 1. Visual Assessment of Enhancement
timeFrame: Up to 24 hours post-dose on Day 1
measure: 2. Adverse Events
timeFrame: From the time of signing Informed Consent through 24 hours post-dose, up to a maximum of 11 days
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Maria Luigia Storto, MD
role: STUDY_DIRECTOR
References: