Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Martini Hospital Groningen | OTHER |
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to intraoperatively visualize tumour tissue in breast cancer patients using fluorescence imaging with the tracer bevacizumab-IRDye800CW and thereby enhance real-time clinical decision making, preventing postoperative tumour-positive margins.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluorescence guided surgery | Experimental | 10 mg bevacizumab-IRDye800CW, to intraoperatively assess possible tumour-positive margins. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorescence guided detection of tumor positive margins. | Procedure | Intraoperative fluorescence imaging detection of tumor positive margins using the targeted tracer bevacizumab-IRDye800CW. |
| Measure | Description | Time Frame |
|---|---|---|
| Detection | To determine whether real-time tumor visualization using targeted fluorescent imaging during breast conserving therapy in breast cancer patients can be achieved intraoperatively and results in adequate assessment of the tumor margin. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Detection ex-vivo imaging | To determine whether ex-vivo fluorescence imaging can adequately show tumor-positive margins in resected tissue samples. | 1 year |
| Detection in-vivo imaging | To determine whether in-vivo fluorescence imaging can adequately show residual tumor in the cavity. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Recruiting | Groningen | 9713GZ | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 year |
| Radical resection rate | To analyze whether patients that in standard-of-care would have tumor-positive margins and needed additional treatment postoperatively, had a radical resection after biopsy using fluorescence guided surgery. | 1 year |
| Martini Ziekenhuis | Recruiting | Groningen | 9728NT | Netherlands |
|
| D017437 |
| Skin and Connective Tissue Diseases |