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Feasibility Study of Using Molecular Fluorescence Guided Surgery in Endometriosis (Endo-light)

Primary Purpose

Endometriosis

Status
Unknown status
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Bevacizumab-800CW
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Females aged ≥ 18 years
  2. Scheduled for surgery for the treatment of endometriosis
  3. WHO performance score of 0-2

  4. Written informed consent

    For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal:

  5. A negative serum pregnancy test prior to receiving the tracer
  6. Willing to ensure that she or her partner uses effective contraception during the trial and for 6 months thereafter.

Exclusion Criteria:

  1. Medical or psychiatric conditions that compromise the patient's ability to give informed consent
  2. Pregnancy
  3. History of infusion reactions to Bevacizumab or other monoclonal antibody therapies
  4. Significant renal, cardiac, or pulmonary disease (ASA III-IV)

Sites / Locations

  • University Medical Center GroningenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

4.5mg Bevacizumab-800CW intravenously

Outcomes

Primary Outcome Measures

Tracer accumulation of bevacizumab-800cw in endometriosis lesions assessed by ex vivo measurement of the mean fluorescent intensity correlated to histopathology

Secondary Outcome Measures

Number of participants with treatment-related adverse events

Full Information

First Posted
November 17, 2016
Last Updated
June 26, 2017
Sponsor
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT02975219
Brief Title
Feasibility Study of Using Molecular Fluorescence Guided Surgery in Endometriosis
Acronym
Endo-light
Official Title
Determine the Feasibility of Detecting Endometriosis During Surgery Using a Molecular Targeted Fluorescent Imaging Tracer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

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
Incomplete resection of endometriosis lesions often results in recurrence of symptoms and the need for repeated surgery, with considerable associated morbidity. The aim of this pilot project is to determine the feasibility of fluorescence imaging to improve the treatment of endometriosis in the future.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
4.5mg Bevacizumab-800CW intravenously
Intervention Type
Drug
Intervention Name(s)
Bevacizumab-800CW
Other Intervention Name(s)
Bevacizumab-IRDye800CW
Intervention Description
4.5mg Bevacizumab-800CW will be administered intravenously three days prior to surgery
Primary Outcome Measure Information:
Title
Tracer accumulation of bevacizumab-800cw in endometriosis lesions assessed by ex vivo measurement of the mean fluorescent intensity correlated to histopathology
Time Frame
within 6 months after surgery
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events
Time Frame
within two weeks after tracer injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females aged ≥ 18 years Scheduled for surgery for the treatment of endometriosis WHO performance score of 0-2 Written informed consent For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal: A negative serum pregnancy test prior to receiving the tracer Willing to ensure that she or her partner uses effective contraception during the trial and for 6 months thereafter. Exclusion Criteria: Medical or psychiatric conditions that compromise the patient's ability to give informed consent Pregnancy History of infusion reactions to Bevacizumab or other monoclonal antibody therapies Significant renal, cardiac, or pulmonary disease (ASA III-IV)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gooitzen van Dam, prof dr
Phone
0503610183
Email
g.m.van.dam@umcg.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gooitzen van Dam, prof dr
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Go M. van Dam, MD, PhD
Phone
+31 50 361 0183
Email
g.m.van.dam@umcg.nl
First Name & Middle Initial & Last Name & Degree
Go M. van Dam, MD, PhD

12. IPD Sharing Statement

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Feasibility Study of Using Molecular Fluorescence Guided Surgery in Endometriosis

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