Feasibility Study of Using Molecular Fluorescence Guided Surgery in Endometriosis

Phase 1

• Conditions: Endometriosis
• Interventions: Drug: Bevacizumab-800CW

• Registration Number: NCT02975219
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-17
• Study First Submitted QC: 2016-11-23
• Study First Posted: 2016-11-29
• Study Start: 2017-05-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-26
• Last Update Posted: 2017-06-27
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Bevacizumab-800CW	4.5mg Bevacizumab-800CW intravenously

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events	within two weeks after tracer injection

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands