Clinical trial NCT02038985: Fluorescence Imaging + ICG Dye for Use in the Visual Diagnosis of Endometriosis
Official title: An Evaluation of Fluorescence Imaging + ICG Dye (Firefly) for Use in the Visual Diagnosis of Endometriosis: A Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Endometriosis
Keywords: Endometriosis
Robotic Surgery
Diagnostic Imaging
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2014-01-17
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of fluorescence imaging using + ICG dye (Firefly).
timeFrame: 1 hour
Secondary outcomes:
measure: Quality of Life
timeFrame: 3 months
Other outcomes:
Locations:
city: Celebration
country: United States
facility: Florida Hospital Celebration Health
state: Florida
Study officials:
affiliation: Florida Hospital Celebration Health
name: Aileen Caceres, MD
role: PRINCIPAL_INVESTIGATOR
References: