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

University Medical Center Groningen (UMCG)

Status and phase: Unknown; Phase 1

Conditions: Endometriosis

Treatments: Drug: Bevacizumab-800CW

Study type: Interventional

Funder types: Other

Identifiers

NCT02975219

2016/304

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment group

Experimental group

Description:

4.5mg Bevacizumab-800CW intravenously

Treatment:

Drug: Bevacizumab-800CW