Soft Tissue Sarcoma
Conditions
Brief summary
There is a need for better visualization of resection margins during surgery for soft tissue sarcoma. Optical molecular imaging of soft tissue sarcoma associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF-A) is overexpressed in soft tissue sarcoma versus normal tissue and has proven to be a valid target for molecular imaging. VEGF-A can be targeted by the monoclonal antibody bevacizumab. Monoclonal antibodies can be labeled by the near-infrared (NIR) fluorescent dye IRDye800CW (800CW). The investigators hypothesize that bevacizumab-800CW accumulates in VEGF expressing cancer, enabling soft tissue sarcoma visualization using a NIR intraoperative camera system. In this pilot intervention study the investigators will determine the optimal dosage of bevacizumab-800CW (10, 25 or 50mg) to detect soft tissue sarcoma intraoperatively.
Interventions
dose finding:10mg; 25mg; 50mg
Sponsors
University Medical Center Groningen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
phase I/II safety and dose-finding study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Patients with soft tissue sarcoma who are scheduled to undergo surgical intervention with curative intent * World Health Organization (WHO) performance score 0-2. * Signed written informed consent
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, Transient Ischemic Attack, Cerebral Vascular Accident, pulmonary embolism, uncontrolled chronic hepatic failure, unstable angina pectoris.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tracer detection | up to 6 months | Determine if accumulation of the fluorescent tracer bevacizumab-800CW can be detected with an intraoperative near infrared camera system to identify soft tissue sarcoma tissue during surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Dose finding | up to 6 months | Identify two doses of the NIR antibody tracer conjugate that provide the best visualization of tumour tissue during surgery |
| Part 1: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | up to 6 months | To obtain information safety aspects of the tracer, side effects, adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR) |
| Part 2: Optimal dose | up to 6 months | Define which of the two doses of conjugate identified in part 1 is the optimal dose for further development in a phase II trial |
Countries
Netherlands
Outcome results
None listed