NL-OMON42239CompletedPhase 2
Phase II, Open-Label Study to Evaluate Safety and Explore Efficacy of Escalating Doses of Bevacizumab-IRDye800CW as an Optical Imaging Agent to Detect Cancer Tissue Delineation during Tumor Resection Surgery in Patients with Breast Cancer - Breast-cancer Fluorescence Guided Surgery
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 26
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
Inclusion Criteria
- •1. Females aged >= 18 years.
- •2. Confirmed diagnosis of breast cancer by means of histology or cytology and eligible for breast cancer surgery.
- •3. Tumor size >= 5 mm (0, 5 cm) diameter according to anatomical imaging data.
- •4. WHO performance score 0-2.
- •5. Life expectancy greater than 12 weeks
- •6. Written informed consent has been obtained
- •7. In the Investigator*s opinion, patient is able and willing to comply with all trial requirements
- •8. A negative serum pregnancy test within 2 weeks prior to receiving the second generation tracer
- •9. Willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter.
Exclusion Criteria
- •1. Medical or psychiatric conditions that compromise the patient*s ability to give informed consent
- •2. Breast prosthesis in the target breast
- •3. History of infusion reactions to Bevacizumab or other monoclonal antibody therapies
- •4. Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last 6 weeks prior to the start of the treatment
- •5. Unresolved chronic non-hematological toxicity higher than NCI-CTC grade 2
- •6. Participation in a clinical study involving an investigational drug or device within 30 days prior to the start of treatment
- •7. Significant renal or hepatic impairment.
- •8. Scheduled elective surgery, with the exception of the breast surgical procedure, or other procedures requiring general anesthesia during the trial.
- •9. Inadequately controlled hypertension with or without current antihypertensive medications.
- •10. History of myocardial infarction (MI), TIA, CVA, pulmonary embolism, uncontrolled congestive heart failure (CHF), significant liver disease, unstable angina within 6 months prior to enrollment.
- •11. Patients receiving anticoagulant therapy with vitamin K antagonists.
- •12. Patients receiving Class IA (e.g. Quinidine, Procanamide) or Class III (e.g. Dofetilide, Amiodarone, Sotalol) antiarrhythmic agents.
- •13. Evidence of QT prolongation on pre-treatment ECG (Males >440 ms, Females >450 ms).
- •14. Magnesium, potassium and calcium levels below LLN which is regarded clinically relevant with regards to study participation.
- •15. Preoperatively undetectable lymphnodes using 99m-TC SPECT-scan that leads to the need of using Patent Blue intraoperatively.
Investigators
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