Primary breast cancer MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Beva800
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BEVACIZUMAB-IRDye 800CW
CAS Number: 216974-75-3
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
Bracco Imaging Spa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female participant =18 years of age; • Is able to give written informed consent and is willing to comply with the protocol requirements; • Is scheduled to undergo breast conserving surgery. 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 55 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Is a pregnant or lactating female. Exclude the possibility of pregnancy: • by testing on site at the institution (serum or urine ßHCG) within prior to the start of investigational product administration, • by surgical history (e.g., Tubenligatur oder Hysterektomie), • post-menopausal with a minimum 1 year without menses; • Has any known allergy to one or more of the ingredients of the investigational product or the bevacizumab; • Has received or is scheduled to receive neo-adjuvant chemo- and/or radiotherapy; • Has received an investigational compound and/or medical device within 30 days before admission into this study; • Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations; • Is determined by the Investigator that the subject is clinically unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the efficacy of fluorescence imaging using the 4.5 mg of the fluorescent tracer, Beva800 at reducing the rate of positive tumor margins compared to standard-of-care BCS; • To obtain additional safety data on exposure of breast cancer patients to 4.5 mg Beva800. ;Secondary Objective: • To evaluate the surgical re-excision rate following BCS with use of fluorescence imaging with Beva800 and the Explorer Air camera within the first 30 days after surgery.;Primary end point(s): For assessment of positive margins after standard of care and MFGS, the specimens from the surgery will be examined according to the standard of care histopathology analysis. Details of tumor dimensions, location (single or multiple regions; right or left breast) along with all other histopathology minimum dataset items will be collected. The distance from the tumor to the radial margins (medial, lateral, superior, inferior, posterior and anterior) will be collected. Individual shavings will be examined according to standard of care histopathology analysis. Efficacy is determined by the number of patients in which a positive margin could be identified using fluorescence guided surgery but not using standard of care. The results per patient will be divided into two clusters, results after standard of care and results after fluorescence guided surgery, according to their margin status. The following criteria will be applied for the assessment of positive or negative margin: Positive margin (invasive carcinoma) = ink on tumor (=tumor cells at the resection margin) Positive margin (DCIS) = tumor cells within 2 mm distance from the resection margin Negative margin (invasive carcinoma) = no tumor cells at the resection margin Negative margin (DCIS) = no tumor cells within 2 mm distance from the resection margin. Need for re-operation will be collected within 30 days post breast surgery.;Timepoint(s) of evaluation of this end point: Immediately after fluorescence guided s | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Germany
Contacts
Public ContactPaola Pianezzola
Bracco Imaging SpA
Outcome results
None listed