soft tissue sarcoma
Conditions
Interventions
In part one, a maximum of 9 patients will receive a single bolus injection of
bevacizumab-800CW three days before surgery. During surgery three imaging
moments are defined in which the near infrared
fluorescence
soft tissue sarcoma
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: *- Age * 18 years. ;*- Patients with proven soft tissue sarcoma who are scheduled to undergo surgical intervention with curative intent;*- WHO performance score 0-2.
Exclusion criteria
Exclusion criteria: *- Medical or psychiatric conditions that compromise the patient*s ability to give informed consent. ;*- Other invasive malignancy ;*- Pregnant or lactating women. Documentation of a negative pregnancy test must be available for woman of childbearing potential. Woman of childbearing potential are pre- menopausal women with intact reproductive organs and women less than two years after menopause. ;*- History of infusion reactions to bevacizumab or other monoclonal antibody therapies. ;*- Inadequately controlled hypertension with or without current antihypertensive medications;*- Within 6 months prior to inclusion: myocardial infarction, TIA, CVA pulmonary embolism, uncontrolled chronic hepatic failure, unstable angina pectoris.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Intraoperative assessment of positive margins based on fluorescent images. - Off table imaging of surgical specimen directly after excision to identify positive margins based on ex vivo fluorescent images. - Standard histopathological examination to confirm higher fluorescent signals in tumour tissue compared to normal tissue. - Calculating target to background ratios in fluorescence images obtained during and directly after the surgical procedure and fluorescence images obtained during ex vivo analyses in bread loaf slices and in histological slices (BlackBox imaging system, Odyssey scanner, fluorescence microscopy). - Adverse events (AE), serious adverse events (SAE), and suspected unexpected serious adverse reactions (SUSARSs). | — |
Countries
The Netherlands
Outcome results
None listed