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

NCT03935165 | Completed Phase 2

• 1 other identifier: 736513. A 287 / C.E./2013
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Endometriosis; Endometriosis Outside Pelvis

Keywords

indocyanine Green; deep Infiltrating Endometriosis; near-Infrared Vision; occult endometriosis; invisible endometriosis

Outcome Measures

Primary Outcomes (1)

• Localization of occult endometriotic lesion

  To detect occult endometriotic lesions, thanks to the fluorescence of the Indocyanine Green, that would remain otherwise not visible to the surgeon eye

  Intraoperative

Secondary Outcomes (4)

• Sensibility and Specificity of Near Infrared Vision with Indocyanine green in detection of endometriotic lesions

  Intraoperative

• Operatory Time

  Intraoperative

• Complications

  From operatory room up to 3 days

• Side effects

  From operatory room up to 3 days

Study Arms (1)

Indocyanine Green arm

EXPERIMENTAL

All the patients to be enrolled have to meet the inclusion criteria. All enrolled patient is subjected, during laparoscopy, to an accurate inspection of the abdomen and all the visible endometriotic lesions are described. Subsequently, 0.25 mg /(kg BW) Indocyanine Green is administered intravenously during surgery and a second look of the abdomen and pelvis with the Near Infrared Vision is made, in order to identify the fluorescent lesions. All the lesions are described and localized pre and post the Indocyanine Green injection and then removed and properly cataloged.

Drug: Indocyanine Green

Interventions

Indocyanine Green DRUG

0.25 mg /(kg BW) Indocyanine Green PULSION®/ VERDYE Diagnostic Green® \- Indocyanine Green is administered Intravenously

Indocyanine Green arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Suspected endometriosis with necessity for laparoscopic confirmation and resection
• Regular menstrual cycles

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of Sacred Heart

Rome, RM, 00100, Italy

Location

Related Publications (2)

• Cosentino F, Vizzielli G, Turco LC, Fagotti A, Cianci S, Vargiu V, Zannoni GF, Ferrandina G, Scambia G. Near-Infrared Imaging with Indocyanine Green for Detection of Endometriosis Lesions (Gre-Endo Trial): A Pilot Study. J Minim Invasive Gynecol. 2018 Nov-Dec;25(7):1249-1254. doi: 10.1016/j.jmig.2018.02.023. Epub 2018 Mar 15.

  PMID: 29551477 BACKGROUND

• Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.

  PMID: 2702835 RESULT

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Francesco Cosentino, MD

  Fondazione di Ricerca e Cura Giovanni Paolo II , Campobasso , Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Women's and Children's Health, Policlinico Agostino Gemelli Foundation University Hospital, Rome, Italy

Model Details: In the selected patients, after a first white light visual inspection, 0.25 mg/(kg BW) ICG were injected intravenously. After 15 to 30 minutes a second inspection of the abdomen and pelvis in Near Infrared vision was made. All the visualized lesions were carefully described pre and post the Indocyanine Green injection, removed and listed

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 2, 2019
• Study Start: January 4, 2016
• Primary Completion: May 19, 2019
• Study Completion: May 19, 2019
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)