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

June 26, 2017 updated by: G.M. van Dam, University Medical Center Groningen

Determine the Feasibility of Detecting Endometriosis During Surgery Using a Molecular Targeted Fluorescent Imaging Tracer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • University Medical Center Groningen
        • Contact:
        • Principal Investigator:
          • Go M. van Dam, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment group
4.5mg Bevacizumab-800CW intravenously
Drug: Bevacizumab-800CW
4.5mg Bevacizumab-800CW will be administered intravenously three days prior to surgery
Other Names:
  • Bevacizumab-IRDye800CW

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
within 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-related adverse events
Time Frame: within two weeks after tracer injection
within two weeks after tracer injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Gooitzen van Dam, prof dr, UMCG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2017

Primary Completion (ANTICIPATED)

January 1, 2019

Study Completion (ANTICIPATED)

January 1, 2019

Study Registration Dates

First Submitted

November 17, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (ESTIMATE)

November 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 27, 2017

Last Update Submitted That Met QC Criteria

June 26, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/304

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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