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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03913806
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Information provided by (Responsible Party):
G.M. van Dam, 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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Drug: Bevacizumab-IRDye800CW Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Intervention Model: Single Group Assignment
Intervention Model Description: phase I/II safety and dose-finding study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: FLuoresence Image Guided Surgery With A VEGF-targeted Tracer in Soft-tissue Sarcomas in Humans (FLASH)- A Feasibility Dose Escalation Study
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: Treatment group
Drug: Bevacizumab-IRDye800CW
dose finding:10mg; 25mg; 50mg

Primary Outcome Measures :
  1. Tracer detection [ Time Frame: 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 :
  1. Part 1: Dose finding [ Time Frame: up to 6 months ]
    Identify two doses of the NIR antibody tracer conjugate that provide the best visualization of tumour tissue during surgery

  2. Part 1: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 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)

  3. Part 2: Optimal dose [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03913806

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Contact: Gooitzen van Dam, MD, PhD 0031503610183

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University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Contact: Go M. van Dam, MD, PhD    +31 50 361 0183   
Principal Investigator: Go M. van Dam, MD, PhD         
Sponsors and Collaborators
University Medical Center Groningen
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Principal Investigator: Gooitzen van Dam, MD, PhD UMCG

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Responsible Party: G.M. van Dam, Professor of Surgery, Principal Investigator, University Medical Center Groningen Identifier: NCT03913806     History of Changes
Other Study ID Numbers: NL61739.042.17
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors