Feasibility Study of Using Molecular Fluorescence Guided Surgery in Endometriosis

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Treatments: Bevacizumab

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)