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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)

Primary Purpose

Soft Tissue Sarcoma

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Bevacizumab-IRDye800CW
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Soft Tissue Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Medical Center Groningen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

Bevacizumab-IRDye800CW

Outcomes

Primary Outcome Measures

Tracer detection
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

Part 1: Dose finding
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
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
Define which of the two doses of conjugate identified in part 1 is the optimal dose for further development in a phase II trial

Full Information

First Posted
May 14, 2018
Last Updated
January 27, 2020
Sponsor
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT03913806
Brief Title
FLuoresence Image Guided Surgery With A VEGF-targeted Tracer in Soft-tissue Sarcomas in Humans Approach With Bevacizumab-IRDye 800CW
Acronym
FLASH
Official Title
FLuoresence Image Guided Surgery With A VEGF-targeted Tracer in Soft-tissue Sarcomas in Humans (FLASH)- A Feasibility Dose Escalation Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
December 22, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
phase I/II safety and dose-finding study
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Bevacizumab-IRDye800CW
Intervention Type
Drug
Intervention Name(s)
Bevacizumab-IRDye800CW
Intervention Description
dose finding:10mg; 25mg; 50mg
Primary Outcome Measure Information:
Title
Tracer detection
Description
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
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Part 1: Dose finding
Description
Identify two doses of the NIR antibody tracer conjugate that provide the best visualization of tumour tissue during surgery
Time Frame
up to 6 months
Title
Part 1: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
To obtain information safety aspects of the tracer, side effects, adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR)
Time Frame
up to 6 months
Title
Part 2: Optimal dose
Description
Define which of the two doses of conjugate identified in part 1 is the optimal dose for further development in a phase II trial
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gooitzen van Dam, MD, PhD
Organizational Affiliation
UMCG
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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