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

Phase 1

Completed

• Conditions: Soft Tissue Sarcoma
• Interventions: Drug: Bevacizumab-IRDye800CW

• Registration Number: NCT03913806
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2018-05-14
• Study First Submitted QC: 2019-04-10
• Study First Posted: 2019-04-12
• Primary Completion: 2019-12-22
• Status Verified: 2020-01
• Study Completion: 2020-01-01
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Bevacizumab-IRDye800CW	Bevacizumab-IRDye800CW

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands