FLuoresence Image Guided Surgery With A VEGF-targeted Tracer in Soft-tissue Sarcomas in Humans Approach With Bevacizumab-IRDye 800CW (FLASH)

University Medical Center Groningen (UMCG)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Soft Tissue Sarcoma

Treatments

Drug: Bevacizumab-IRDye800CW

Study type

Interventional

Funder types

Other

Identifiers

NCT03913806

NL61739.042.17

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.