Female breast cancer patients with small tumor size in which breast conserving therapy is advised by the multidisciplinary tumor board.
Conditions
Interventions
Trade Name: Bevacizumab
Product Name: Bevacizumab-IRDye800CW
Product Code: Bevacizumab-IRDye800CW
Pharmaceutical Form: Solution for infusion
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, the subject must meet all the following criteria: -Patients are females with histologically proven carcinoma of the breast -The carcinoma of the breast is a local disease with limited size (but tumor size = 0.5cm) and in the multidisciplinary tumor board meeting breast conserving therapy is advised -Age = 18 years -Written informed consent has been obtained -Women of childbearing potential (premenopausal women with intact reproductive organs and women less than two years after menopause) require use of effective contraception at least 3 months before administration of the tracer (if not, a negative serum pregnancy test has to be submitted), and they need to be willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: -Medical or psychiatric conditions that compromise the patient’s ability to give informed consent -Non palpable breast tumor or prior surgery of this breast -Received an investigational drug within 30 days prior to bevacizumab-IRDye800CW -Received neo-adjuvant therapy -History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure or unstable angina within 6 months prior to enrollment -Inadequately controlled hypertension with or without current antihypertensive medication -Significant renal or hepatic impairment (grade II or higher deviations by CTCAE) -History of allergy or infusion reactions bevacizumab or other monoclonal antibodies -Pregnant or lactating women -Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents -Life expectancy < 12 weeks -Preoperatively undetectable lymph nodes using SPECT-scan, requiring the use of patent blue.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether real-time tumor visualization using targeted fluorescent imaging during BCT in breast cancer patients can be achieved intraoperatively and results in adequate assessment of the tumor margin. ;Secondary Objective: To determine whether ex-vivo fluorescence imaging can adequately show tumor-positive margins in resected tissue samples. To determine whether in-vivo fluorescence imaging can adequately show residual tumor in the cavity. To determine whether one of the above-mentioned imaging techniques is superior to the other in assessing tumor margin or that both techniques should be used together. To determine whether the fluorescence images do correlate with pathology and fluorescence shows the presence of tumor-positive margins as hypothesized. 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 FGS. ;Primary end point(s): Tumor-positive margin detection rate in breast cancer patients undergoing BCT of real-time, intraoperative, ex-vivo and in-vivo fluorescence imaging measurements using bevacizumab-IRDye800CW.;Timepoint(s) of evaluation of this end point: End of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Presence of tumor-positive margins as assessed by ex-vivo imaging of the resected tissue specimen. -Presence of residual tumor as assessed by in-vivo imaging of the cavity intraoperatively. -Tumor margins as obtained following standard histopathological practice. -Histopathological analysis of biopsies taken from region of interest in the cavity and resected specimen. -Patients with radical resection after taking biopsy based on FGS. ;Timepoint(s) of evaluation of this end point: End of the study | — |
Countries
Netherlands
Contacts
Public ContactDep. of Nucl.Med.&Mol.Imag. (NGMB)
University Medical Center Groningen
Outcome results
None listed