Ovarian Cancer
Conditions
Brief 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.
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.
Interventions
DRUGBR55
A novel targeted ultrasound contrast agent
Sponsors
National Institutes of Health (NIH)
Bracco Diagnostics, Inc
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Assessment of BR55 Enhancement | 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 | 2 days (day of and 24 hours after BR55 administration) | Number of participants who received the contrast agent and experienced an adverse event. |
Countries
United States
Participant flow
Recruitment details
A total of 60 subjects scheduled to undergo salpingo-oophorectomy within 30 days of BR55 contrast-enhanced ultrasound (CEUS) examination were to be enrolled to obtain approx. 30 subjects with benign ovarian lesions and 30 with malignant ovarian lesions based on the Truth Standard (TS; histopathology). This study was terminated early due to expiration of available BR55, therefore, only 14 of the 60 anticipated participants in the study were enrolled.
Pre-assignment details
A subject was to be enrolled in the study if the following inclusion criteria were met: was at least 18 years old; had an ovarian lesion that was visible and assessable with trans-vaginal ultrasound; was scheduled to undergo salpingo-oophorectomy for suspected ovarian cancer not earlier than 24 hours and not later than 30 days following BR55 administration; and provided written Informed Consent and was willing to comply with protocol requirements.
Participants by arm
| Arm | Count |
|---|---|
| Treatment All subjects received a single dose of BR55 at 0.03 mL/kg in this study. No subject received a single dose of BR55 at 0.05 mL/kg.
BR55: A novel targeted ultrasound contrast agent | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Surgery not performed | 1 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 55.4 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Exposure to Investigational Product | 2.16 Actual Volume Administered (mL) STANDARD_DEVIATION 0.246 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 3 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Adverse Events
Number of participants who received the contrast agent and experienced an adverse event.
Time frame: 2 days (day of and 24 hours after BR55 administration)
Population: All participants enrolled and dosed in the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Adverse Events | 3 Participants |
Primary
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).
Time frame: 30 minutes post-dose on Day 1
Population: All participants enrolled and dosed in the study with BR55 enhancement assessed at 30 minutes post-dose timepoint.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment | Visual Assessment of BR55 Enhancement | No enhancement | 5 Participants |
| Treatment | Visual Assessment of BR55 Enhancement | Weak enhancement | 6 Participants |
| Treatment | Visual Assessment of BR55 Enhancement | Strong enhancement | 3 Participants |