Feasibility Study of Using Molecular Fluorescence Guided Surgery in Endometriosis
Endo-light
Determine the Feasibility of Detecting Endometriosis During Surgery Using a Molecular Targeted Fluorescent Imaging Tracer
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2016
CompletedFirst Posted
Study publicly available on registry
November 29, 2016
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedJune 27, 2017
June 1, 2017
1.7 years
November 17, 2016
June 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Tracer accumulation of bevacizumab-800cw in endometriosis lesions assessed by ex vivo measurement of the mean fluorescent intensity correlated to histopathology
within 6 months after surgery
Secondary Outcomes (1)
Number of participants with treatment-related adverse events
within two weeks after tracer injection
Study Arms (1)
Treatment group
EXPERIMENTAL4.5mg Bevacizumab-800CW intravenously
Interventions
4.5mg Bevacizumab-800CW will be administered intravenously three days prior to surgery
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gooitzen van Dam, prof dr
University Medical Center Groningen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- prof. dr.
Study Record Dates
First Submitted
November 17, 2016
First Posted
November 29, 2016
Study Start
May 1, 2017
Primary Completion
January 1, 2019
Study Completion
January 1, 2019
Last Updated
June 27, 2017
Record last verified: 2017-06