Feasibility Study of Using Molecular Fluorescence Guided Surgery in Endometriosis

Endometriosis Clinical Trial

— Endo-light  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02975219
• Other study ID #: 2016/304
• Status: Recruiting
• Phase: Phase 1
• First received: November 17, 2016
• Last updated: June 26, 2017
• Start date: May 1, 2017
• Est. completion date: January 2019

Study information

• Verified date: June 2017
• Source: University Medical Center Groningen
• Contact: Gooitzen van Dam, prof dr
• Phone: 0503610183
• Email: g.m.van.dam[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Bevacizumab-800CW
4.5mg Bevacizumab-800CW will be administered intravenously three days prior to surgery

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with treatment-related adverse events		within two weeks after tracer injection