NCT03493464

BR55 in Characterization of Ovarian Lesions

Terminated Phase 2 Results posted Last updated 19 September 2024

What this trial tests

Phase 2 trial testing BR55 in Ovarian Cancer in 14 participants. Terminated before completion.

Timeline

13 December 2018

Primary endpoint
15 April 2021

31 July 2021

Quick facts

Lead sponsor	Bracco Diagnostics, Inc
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	diagnostic
Enrollment	14
Start date	13 December 2018
Primary completion	15 April 2021
Estimated completion	31 July 2021
Sites	1 location across United States

Drugs / interventions tested

• BR55 — full drug profile →

Conditions studied

• Ovarian Cancer — all drugs for Ovarian Cancer →

Sponsor

Bracco Diagnostics, Inc — full company profile →

Who can join

18 and older, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Visual Assessment of BR55 Enhancement Primary · 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).

Group	Value	95% CI
Treatment	5
Treatment	6
Treatment	3

Adverse Events Primary · 2 days (day of and 24 hours after BR55 administration)

Number of participants who received the contrast agent and experienced an adverse event.

Group	Value	95% CI
Treatment	3

Adverse events — posted to ClinicalTrials.gov

Time frame: Safety monitoring began at the time of signing Informed Consent and continued for 24 hours after BR55 administration, up to 3 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment

Serious: 0/14 (0%)

Deaths: 0/14

Other adverse events (2 terms — click to expand)

Reaction	System	Treatment
Headache	Nervous system disorders	—
Itchiness	General disorders	—

Data from ClinicalTrials.gov NCT03493464 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Molecular Ultrasound Imaging.
   Köse G, Darguzyte M, Kiessling F. · · 2020 · cited 46× · PMID 32998422 · DOI 10.3390/nano10101935
2. Current status of targeted microbubbles in diagnostic molecular imaging of pancreatic cancer.
   Jugniot N, Bam R, Meuillet EJ, Unger EC, et al · · 2021 · cited 20× · PMID 33532585 · DOI 10.1002/btm2.10183