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| Name | Class |
|---|---|
| Martini Hospital Groningen | OTHER |
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A need for further investigation for fluorescence image-guided surgery in breast conserving surgery (BCS) has arisen following the results obtained from a phase I feasibility breast cancer trial (BIRDYE study: ABR NL 37479.042011). The aim of this study is to define the optimal dose of the fluorescent tracer Bevacizumab-IRDye800CW for intraoperative delineation of breast cancer tissue using the improved and optimized fluorescent tracer and camera system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | In part 1 a dose escalation will be performed for the tracer bevacizumab-800CW in four different dose groups (4,5mg 10mg 25mg 50mg) |
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| Part 2 | Experimental | In part 2, the two best performing dose groups of bevacizumab-800CW of part 1 will be expanded to a total of 10 patients per group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab-800CW | Drug | three days prior to surgery bevacizumab-800CW will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor-to-background ratio | day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | up to two weeks |
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Main Inclusion Criteria:
Females aged ≥ 18 years.
Confirmed diagnosis of breast cancer by means of histology or cytology and eligible for breast cancer surgery.
Tumor size ≥ 5 mm (0, 5 cm) diameter according to anatomical imaging data.
WHO performance score 0-2.
Life expectancy greater than 12 weeks
Written informed consent has been obtained
In the Investigator's opinion, patient is able and willing to comply with all trial requirements.
For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal:
A negative serum pregnancy test prior to receiving the second generation tracer
Willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter.
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| G.M van Dam, prof. dr. | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | Provincie Groningen | 9713 GZ | Netherlands |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |