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

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ClinicalTrials.gov Identifier: NCT02975219
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
G.M. van Dam, University Medical Center Groningen

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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Bevacizumab-800CW Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determine the Feasibility of Detecting Endometriosis During Surgery Using a Molecular Targeted Fluorescent Imaging Tracer
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
Drug Information available for: Bevacizumab

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 Name: Bevacizumab-IRDye800CW




Primary Outcome Measures :
  1. 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 Measures :
  1. Number of participants with treatment-related adverse events [ Time Frame: within two weeks after tracer injection ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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 ClinicalTrials.gov identifier (NCT number): NCT02975219


Contacts
Contact: Gooitzen van Dam, prof dr 0503610183 g.m.van.dam@umcg.nl

Locations
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Contact: Go M. van Dam, MD, PhD    +31 50 361 0183    g.m.van.dam@umcg.nl   
Principal Investigator: Go M. van Dam, MD, PhD         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Principal Investigator: Gooitzen van Dam, prof dr UMCG

Responsible Party: G.M. van Dam, prof. dr., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02975219     History of Changes
Other Study ID Numbers: 2016/304
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents