BR55 in Characterization of Ovarian Lesions (NCT03493464) | Clinical Trial Compass
TerminatedPhase 2
BR55 in Characterization of Ovarian Lesions
Stopped: Sponsor decision; expiration of available study agent due to long recruitment timeline.
United States14 participantsStarted 2018-12-13
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 assoc…
What they're measuring
1
Visual Assessment of BR55 Enhancement
Timeframe: 30 minutes post-dose on Day 1
2
Adverse Events
Timeframe: 2 days (day of and 24 hours after BR55 administration)