Prospective Evaluation of Near-infrared Fluorescence Imaging Use as a Supportive Tool in Deep Infiltrating Endometriosis Surgery

• Status: Completed
• Trial end date: 2019-05-19
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of the study is to establish a new and more accurate method to visualize the peritoneal changes caused by endometriosis using Indocyanine Green mediated fluorescence imaging. The hypothesis is that Indocyanine Green, a fluorescent dye that has wide applications throughout medicine in identifying vascularity of tissues and neo-vascularization, could facilitate the localization and excision of endometriotic lesions exploiting the hypervascularization due to the chronic inflammation. The already published Pilot Study GRE-ENDO (Cosentino F, Near-Infrared Imaging with Indocyanine Green for Detection of Endometriosis Lesions (Gre-Endo Trial): A Pilot Study.), encouraged the effort of a larger prospective trial. Based on the mini-max two-stage design by Simon [Simon R. Optimal two stage design for phase II clinical trials], the investigators tested the null hypothesis that the true rate of pathologically assessed endometriosis would improve from 87% to the clinically relevant alternative of 100.0%, as assessed by NIR-ICG laparoscopy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Catholic University of the Sacred Heart

Criteria

Inclusion Criteria:

• Suspected endometriosis with necessity for laparoscopic confirmation and resection

• Regular menstrual cycles

Exclusion Criteria:

• Patients younger than 18 years and older than 50 years at time of operation

• Subject with previous history of adverse reaction or allergy to Indocyanine Green, iodine, shellfish or iodine dyes

• Documented allergy to sulfur containing compounds

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Indocyanine Green

• Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests (Total bilirubin increased by factor 1.5 than normal and/or serum glutamic oxaloacetic transaminase increased by factor 2 than normal)

• Subject has uremia, serum creatinine (> 2.0 mg/dl)

• Subject has severe coronary heart disease (instable angina pectoris)

• Pregnant or breast-feeding women

• Subject actively participating in another drug, biologic and/or device protocol

• The presence of medical conditions contraindicating general anesthesia or standard surgical approaches

• Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure