Pancreatic Ductal Adenocarcinoma
Conditions
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.
Interventions
DRUGBR55
A novel targeted ultrasound contrast agent
Sponsors
National Institutes of Health (NIH)
Bracco Diagnostics, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. Visual Assessment of Enhancement | 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). |
| 2. Adverse Events | 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. |
Countries
United States
Participant flow
Pre-assignment details
As of July 31, 2021, enrollment was terminated for Study BR55-110 due to expiration of available BR55. Therefore, only 4 participants were enrolled in the first cohort of this study (0.03 mL/kg). No participant was enrolled in the 0.05 mL/kg or 0.08 mL/kg groups.
Participants by arm
| Arm | Count |
|---|---|
| 0.03mL/kg Dose Group A group of up to 8 subjects to receive a single dose of BR55 at 0.03mL/kg.
BR55: A novel targeted ultrasound contrast agent | 4 |
| 0.05mL/kg Dose Group A group of up to 8 subjects to receive a single dose of BR55 at 0.05mL/kg.
BR55: A novel targeted ultrasound contrast agent
No study participant was enrolled in this group. | 0 |
| 0.08mL/kg Dose Group A group of 8 subjects to receive a single dose of BR55 at 0.08mL/kg.
BR55: A novel targeted ultrasound contrast agent
No study participant was enrolled in this group. | 0 |
| Total | 4 |
Baseline characteristics
| Characteristic | 0.03mL/kg Dose Group | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants |
| Age, Continuous | 65.5 years | 65.5 years |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants |
| Region of Enrollment United States | 4 participants | 4 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants |
| Total Volume (mL) Injected | 2.00 mL | 2.00 mL |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 2 / 4 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 4 | 0 / 0 | 0 / 0 |
Outcome results
Primary
1. Visual Assessment of Enhancement
BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement, weak enhancement, strong enhancement).
Time frame: Up to 24 hours post-dose on Day 1
Population: As of July 31, 2021, enrollment was terminated for Study BR55-110 due to expiration of available BR55. Therefore, only 4 participants were enrolled in the first cohort of this study (0.03 mL/kg). No participant was enrolled in the 0.05 mL/kg or 0.08 mL/kg groups.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 0.03mL/kg Dose Group | 1. Visual Assessment of Enhancement | Strong enhancement | 1 Participants |
| 0.03mL/kg Dose Group | 1. Visual Assessment of Enhancement | No enhancement | 0 Participants |
| 0.03mL/kg Dose Group | 1. Visual Assessment of Enhancement | Weak enhancement | 3 Participants |
Primary
2. Adverse Events
Number of participants who received the contrast agent and experienced an adverse event.
Time frame: From the time of signing Informed Consent through 24 hours post-dose, up to a maximum of 11 days
Population: As of July 31, 2021, enrollment was terminated for Study BR55-110 due to expiration of available BR55. Therefore, only 4 participants were enrolled in the first cohort of this study (0.03 mL/kg). No participant was enrolled in the 0.05 mL/kg or 0.08 mL/kg groups.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.03mL/kg Dose Group | 2. Adverse Events | 2 Participants |
| 0.05mL/kg Dose Group | 2. Adverse Events | 0 Participants |
| 0.08mL/kg Dose Group | 2. Adverse Events | 0 Participants |