Endometriosis
Conditions
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.
Interventions
4.5mg Bevacizumab-800CW will be administered intravenously three days prior to surgery
Sponsors
University Medical Center Groningen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events | within two weeks after tracer injection |
Countries
Netherlands
Contacts
Primary ContactGooitzen van Dam, prof dr
Outcome results
None listed