BR55 in Characterization of Ovarian Lesions

A Phase 2 study testing BR55 in people with Ovarian Cancer, run by Bracco Diagnostics, Inc at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This is an exploratory phase II, single center, open label, prospective study of BR55 CEUS for characterization of ovarian lesions in subjects with suspected ovarian cancer. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Ovarian Cancer
What is being tested?: BR55
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 13 Dec 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
Women only
No healthy volunteers
Adult, Older adult

Inclusion Criteria: Enroll a subject if he/she meets the following inclusion criteria:

Is at least 18 years of age;
Has an ovarian lesion that is visible and assessable with trans-vaginal ultrasound;
Is scheduled to undergo salpingo-oophorectomy for suspected ovarian cancer 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 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 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 ovarian cancer;
Has history of 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 Investigational Product 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 surgery to the ovaries or pelvic inflammatory disease.

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University Medical Center
Palo Alto, California, 94304

Other trials in United States

About this study

Official title: BR55 Contrast Enhanced Ultrasound (CEUS) in Characterization of Ovarian Lesions

This is an exploratory phase II, single center, open label, prospective study of BR55 CEUS for characterization of ovarian lesions in subjects with suspected ovarian cancer.

Read the detailed description

A total of sixty (60) subjects scheduled to undergo salpingo-oophorectomy within 30 days of BR55 CEUS examination will be enrolled to obtain approximately 30 subjects with benign ovarian lesions and 30 with malignant ovarian lesions based on the truth standard (TS).

The first 10 subjects will receive BR55 at a dose of 0.03 mL/kg. Assuming these first 10 subjects will show technically adequate images, subsequent subjects enrolled in the study will continue to receive 0.03 mL/kg dose of BR55; otherwise, subjects will be switched to a 0.05 mL/kg dose of BR55.

The final cancer diagnosis will be obtained for all subjects by histopathology.

Conditions: Ovarian Cancer
Being tested: BR55
Medical subject headings: Ovarian Neoplasms

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 groups in NCT03493464
Study group	Role	What they receive
Treatment	Experimental	Subjects will receive a single dose of BR55 at 0.03 mL/kg or 0.05 mL/kg. Receives: Drug: BR55

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Assessment of BR55 Enhancement
BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement=no focal targeted, stationary imaging signal was detectable; weak enhancement=weak focal targeted imaging signal was detectable and considered possibly stationary; strong enhancement=well-defined and strong focal targeted imaging signal was detectable and considered as definitely stationary).
Measured: 30 minutes post-dose on Day 1
Adverse Events
Number of participants who received the contrast agent and experienced an adverse event.
Measured: 2 days (day of and 24 hours after BR55 administration)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 201831 Jul 2021

First posted10 Apr 2018
Study start13 Dec 2018
Primary completion15 Apr 2021
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 Ovarian CancerStudies 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: Not applicable
Intervention model: Sequential
Model description: A total of sixty (60) subjects will be evaluated in the study. The first 10 subjects enrolled in the study will receive BR55 at a dose of 0.03 mL/kg. Assuming these first 10 subjects will show technically adequate images, subsequent subjects enrolled in the study will continue to receive 0.03 mL/kg dose of BR55; otherwise, subjects will be switched to a 0.05 mL/kg dose of BR55.
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03493464
Sponsor's protocol ID: BR55-108
Status last verified: Sep 2024
First submitted: 4 Apr 2018
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
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The Vanguard Study: Testing a New Way to Screen for Cancer
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All Ovarian Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BR55 Contrast Enhanced Ultrasound (CEUS) in Characterization of Ovarian Lesions
ClinicalTrials.gov ID: NCT03493464
Acronym / sponsor ID: BR55-108
Conditions: Ovarian Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision; expiration of available study agent due to long recruitment timeline.
Enrolment: 14 participants (actual)
Lead sponsor: Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
Collaborators: National Institutes of Health (NIH)
Study start: 13 Dec 2018 (actual)
Primary completion: 15 Apr 2021 (actual)
Study completion: 31 Jul 2021 (actual)
First posted: 10 Apr 2018 (actual)
Results: Posted 19 Sep 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 phase II, single center, open label, prospective study of BR55 CEUS for characterization of ovarian lesions in subjects with suspected ovarian cancer.

Detailed description

The final cancer diagnosis will be obtained for all subjects by histopathology.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1
Model description: A total of sixty (60) subjects will be evaluated in the study. The first 10 subjects enrolled in the study will receive BR55 at a dose of 0.03 mL/kg. Assuming these first 10 subjects will show technically adequate images, subsequent subjects enrolled in the study will continue to receive 0.03 mL/kg dose of BR55; otherwise, subjects will be switched to a 0.05 mL/kg dose of BR55.

Arm	Type	Receives
Treatment	Experimental	Drug: BR55Subjects will receive a single dose of BR55 at 0.03 mL/kg or 0.05 mL/kg.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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	Treatment

Primary outcome

Visual Assessment of BR55 Enhancement
Time frame: 30 minutes post-dose on Day 1
BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement=no focal targeted, stationary imaging signal was detectable; weak enhancement=weak focal targeted imaging signal was detectable and considered possibly stationary; strong enhancement=well-defined and strong focal targeted imaging signal was detectable and considered as definitely stationary).
Adverse Events
Time frame: 2 days (day of and 24 hours after BR55 administration)
Number of participants who received the contrast agent and experienced an adverse event.

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	14	13

Primary outcome: Visual Assessment of BR55 Enhancement

Time frame: 30 minutes post-dose on Day 1. Count of participants. Unit: Participants

Measure	Treatment n = 14
No enhancement	5
Weak enhancement	6
Strong enhancement	3

Population analysed: All participants enrolled and dosed in the study with BR55 enhancement assessed at 30 minutes post-dose timepoint.

Primary outcome: Adverse Events

Time frame: 2 days (day of and 24 hours after BR55 administration). Count of participants. Unit: Participants

Measure	Treatment n = 14
Value	3

Population analysed: All participants enrolled and dosed in the study

Adverse events

Time frame: Safety monitoring began at the time of signing Informed Consent and continued for 24 hours after BR55 administration, up to 3 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	0 of 14 (0%)	3 of 14 (21.4%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Ovarian Cancer

Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma

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 Ovarian Cancer, 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?

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 19 Sep 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 19 Sep 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?

Visual Assessment of BR55 Enhancement (time frame: 30 minutes 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?

On the ClinicalTrials.gov record for NCT03493464.

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 19 Sep 2024.