FLuoresence image guided surgery with A VEGF-targeted tracer in soft-tissue Sarcomas in Humans

Completed

Conditions: soft tissue sarcoma
10028389
10072990

Registration Number: NL-OMON47633

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 23

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

*- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Intraoperative assessment of positive margins based on fluorescent images.<br /><br>- Off table imaging of surgical specimen directly after excision to identify<br /><br>positive margins based on ex vivo fluorescent images.<br /><br>- Standard histopathological examination to confirm higher fluorescent signals<br /><br>in tumour tissue compared to normal tissue.<br /><br>- Calculating target to background ratios in fluorescence images obtained<br /><br>during and directly after the surgical procedure and fluorescence images<br /><br>obtained during ex vivo analyses in bread loaf slices and in histological<br /><br>slices (BlackBox imaging system, Odyssey scanner, fluorescence microscopy).<br /><br>- Adverse events (AE), serious adverse events (SAE), and suspected unexpected<br /><br>serious adverse reactions (SUSARSs).</p><br>

Secondary Outcome Measures