Feasibility Study of Using Molecular Fluorescence Guided Surgery in Endometriosis

Sponsor
University Medical Center Groningen
Study ID
NCT02975219
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Nov 29, 2016
Start date
May 1, 2017
Status verified
Jun 2017
Primary completion
Jan 31, 2019
Completion
Jan 31, 2019

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    4.5mg Bevacizumab-800CW intravenously

Primary Outcome Measure

Tracer accumulation of bevacizumab-800cw in endometriosis lesions assessed by ex vivo measurement of the mean fluorescent intensity correlated to histopathology [ Time Frame: within 6 months after surgery ]

Central Contacts

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