Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Feasibility study of Bevonescein to highlight Nerves and Ureter in patients undergoing Minimally Invasive Surgery
This study will evaluate the safety, tolerability and efficacy of Bevonescein administered as an intravenous (IV) infusion to patients undergoing minimally invasive surgery. This study will also characterize the pharmacokinetic of Bevonescein in this subject population and determine the dose of Bevonescein needed to generate a fluorescence signal in nerve and ureter tissue to enable fluorescence recordings and image analysis with an imaging system.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Defining | Experimental | A dose defining phase for each surgical setting. |
|
| Dose Expansion | Experimental | A dose expansion phase for each surgical setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevonescein | Drug | Bevonescein is a sterile solution that is intravenously administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fluorescence System Survey | To assess the feasibility of the Fluorescence System in each of the identified Minimally Invasive Surgery settings. | 28 (+5 days) |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the optimal dose of Bevonescein in Minimally Invasive Surgery settings | The optimal dose for each of the identified surgical settings will be assessed by using three doses. | 28 (+5 days) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barbara Stephens | Contact | 6145569561 | barbara.stephens@alumebiosciences.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | Recruiting | San Diego | California | 92037 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will begin with a dose-defining stage in each surgical setting. Once dose defining is complete, the study will proceed to a dose expansion phase for each surgical setting.
Not provided
Not provided
Not provided
Not provided