Fluorescence Imaging + ICG Dye for Use in the Visual Diagnosis of Endometriosis (FIREFLY)

An Evaluation of Fluorescence Imaging + ICG Dye (Firefly) for Use in the Visual Diagnosis of Endometriosis: A Prospective Study

The purpose of this study is to evaluate the use of fluorescence imaging + Indocyanine Green (ICG) dye ("Firefly"), compared to standard white light imaging in 2D and 3D, for accurate visual diagnosis of endometriosis during a da Vinci robotically guided endometriosis resection procedure.

Study Overview

• Status: Terminated
• Conditions: Endometriosis
• Intervention / Treatment: Other: Participants will receive ICG Dye

Detailed Description

Fluorescence imaging has been used for visualization of tissue perfusion in colorectal surgery, detection of pathologic primary and metastatic tumors, and measurement of graft patency in cardiovascular surgery. The da Vinci® Firefly Imaging System, through the use of fluorescence imaging, allows surgeons to view high-resolution near infrared images of blood flow and tissue perfusion in real-time during robotic-assisted surgical procedures, such as during a robotic-assisted endometriosis resection.

Using standard white light imaging, endometriotic lesions can appear red and vascular, white and scarred, black, brown, yellow, or almost any color; atypical implants are clear and can seem like normal tissue. However, there are some published reports demonstrating that the lesions of endometriosis are hypervascular and may be visualized radiographically on the basis of this pathologic feature. Because the individual lesions of endometriosis can vary significantly in their appearance under standard white light, using the hypervascular characteristic of this disease along with the Firefly technology may provide consistency in intraoperative visual diagnosis, and thus may aid the detection and resection of endometriosis.

The ability to accurately visualize all the lesions of endometriosis, typical and atypical in appearance, and thus facilitate complete resection of the disease, may have a significant impact on symptomatic relief and disease recurrence. The Firefly Imaging System of fluorescence imaging + ICG dye may allow for more accurate visual diagnosis of endometriosis during a robotic-assisted endometriosis resection procedure, and therefore may have a positive impact for patients with this disease.

This is a prospective, comparison, single-center, observational study to evaluate fluorescence imaging + ICG dye (Firefly), compared to standard white light imaging in 2D and 3D, for accurate visual diagnosis of endometriosis during a da Vinci endometriosis resection procedure.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Celebration, Florida, United States, 34747
      • Florida Hospital Celebration Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Be premenopausal (menopause is defined as amenorrhea lasting one year or longer)
• Have symptoms consistent with endometriosis, including the presence of one or more of the following: dysmenorrhea; dyspareunia; chronic pelvic pain (>6 months duration); pressure on the bladder or rectum causing difficult or painful bowel movements; infertility.
• Be willing to undergo planned da Vinci Endometriosis Resection Procedure

Exclusion Criteria:

• Known or suspected allergy to iodine, shellfish, or ICG dye
• Presence of medical conditions contraindicating general anesthesia or standard laparoscopic/ robotic surgery
• Active pelvic infection
• Previous history of radiation therapy to the pelvis
• Known or suspected pregnancy
• Presence of anatomy unsuitable for laparoscopic surgery
• Previously undiagnosed intra-abdominal or pelvic malignancy
• Inability of patient to tolerate Trendelenberg position or pneumoperitoneum

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: + ICG Dye (Firefly); Participants will receive ICG Dye	Other: Participants will receive ICG Dye; Participants will receive ICG Dye preoperatively for use in the Visual Diagnosis of Endometriosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of fluorescence imaging using + ICG dye (Firefly).	Quality is defined by the investigators perception of accuracy of visual diagnosis and how clear are the the resultant images used for visualization and mapping of lesions. The quality of the fluorescence imaging + ICG dye (Firefly) will be compared to standard white light imaging in 2D and 3D for accurate visual diagnosis of endometriosis during a da Vinci endometriosis resection procedure	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	Quality of Life (QOL) will be captured by utilizing the validated questionnaire SF-36 short form, administered at three time-points: pre-operative, at 3-months post-operative, and at 6-months post-operative. The QOL aspects examined with the SF-36 include vitality, mental health physical functioning, bodily pain, general health perceptions, as well as physical, emotional, and social role functioning.	3 months

Collaborators and Investigators

• Sponsor: AdventHealth
• Investigators: Principal Investigator: Aileen Caceres, MD, Florida Hospital Celebration Health

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): August 16, 2016

Study Registration Dates

• First Submitted: December 30, 2013
• First Submitted That Met QC Criteria: January 15, 2014
• First Posted (Estimate): January 17, 2014

Study Record Updates

• Last Update Posted (Actual): October 6, 2017
• Last Update Submitted That Met QC Criteria: October 4, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Endometriosis; Robotic Surgery; Diagnostic Imaging
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 451140