Pancreatic Ductal AdenocarcinomaPhase 2NCT03486327
Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions
A Phase 2 study testing BR55 in people with Pancreatic Ductal Adenocarcinoma, run by Bracco Diagnostics, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- BR55
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2018to 31 Jul 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 19Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Palo Alto, California, 94304
About this study
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.
Read the 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.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- BR55
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR55Drug
A novel targeted ultrasound contrast agent
| Study group | Role | What they receive |
|---|---|---|
| 0.03mL/kg Dose Group | Experimental | A group of up to 8 subjects to receive a single dose of BR55 at 0.03mL/kg. Receives: Drug: BR55 |
| 0.05mL/kg Dose Group | Experimental | A group of up to 8 subjects to receive a single dose of BR55 at 0.05mL/kg. Receives: Drug: BR55 |
| 0.08mL/kg Dose Group | Experimental | A group of 8 subjects to receive a single dose of BR55 at 0.08mL/kg. Receives: Drug: BR55 |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Visual Assessment of Enhancement
BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement, weak enhancement, strong enhancement).
Measured: Up to 24 hours post-dose on Day 1
2. Adverse Events
Number of participants who received the contrast agent and experienced an adverse event.
Measured: From the time of signing Informed Consent through 24 hours post-dose, up to a maximum of 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start19 Jul 2018
- Primary completion13 Nov 2020
- Study completion31 Jul 2021
Why it stopped: Sponsor decision; expiration of available study agent due to long recruitment timeline.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bracco Diagnostics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Maria Luigia Storto, MD, Study director, Bracco Diagnostics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486327
- Sponsor's protocol ID
- BR55-110
- Status last verified
- Aug 2024
- First submitted
- 2 Mar 2018
- Last updated
- 23 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions
- ClinicalTrials.gov ID
- NCT03486327
- Acronym / sponsor ID
- BR55-110
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision; expiration of available study agent due to long recruitment timeline.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 13 Nov 2020 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 3 Apr 2018 (actual)
- Results
- Posted 23 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 0.03mL/kg Dose Group | Experimental | Drug: BR55A group of up to 8 subjects to receive a single dose of BR55 at 0.03mL/kg. |
| 0.05mL/kg Dose Group | Experimental | Drug: BR55A group of up to 8 subjects to receive a single dose of BR55 at 0.05mL/kg. |
| 0.08mL/kg Dose Group | Experimental | Drug: BR55A group of 8 subjects to receive a single dose of BR55 at 0.08mL/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BR55A novel targeted ultrasound contrast agent | Drug | 0.03mL/kg Dose Group, 0.05mL/kg Dose Group, 0.08mL/kg Dose Group |
Primary outcome
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).
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Luigia Storto, MD study director
Bracco Diagnostics, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BR55 in people with Pancreatic Ductal Adenocarcinoma, run by Bracco Diagnostics, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Visual Assessment of Enhancement (time frame: Up to 24 hours post-dose on Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.