ICG to Assess Ovarian Perfusion | Clinical Trial

Key information

Conditions

Fibroid Uterus Adenomyosis Connective Tissue Diseases Endometrial Cyst Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Leiomyoma Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Skin and Connective Tissue Diseases Urogenital Diseases Uterine Adenomyosis Uterine Cyst Uterine Diseases Uterine Fibroid Uterus Myoma

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

259 E Erie - Northwestern

Chicago, Illinois, 60611, United States

About this study

The purpose of this study is to determine the feasibility of intravenous ICG administration to facilitate assessments of ovarian vascular perfusion. Historically, assessment of ovarian perfusion has been performed visually or via ultrasound with Doppler evaluation. In patients with ovarian endometriomas, evidence of ovarian interstitial microvascular injury has been demonstrated similarly by the presence of low flow and high RI. The use of ICG to evaluate ovarian perfusion specifically has not been reported. The use of ICG for intraoperative perfusion assessment of the ovary could provide more information about the health of the ovary and inform the surgical approach to ovarian pathology.

ICG will be injected intravenously to assess ovarian perfusion in the presence or absence (control) of pathology. Near infrared fluorescence imaging will be used to illuminate the ICG. The extent of perfusion will be determined using digital imaging software.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients attending a preoperative visit at the Center for Comprehensive Gynecology who will undergo surgery.

Exclusion criteria

Not able to comprehend and sign a written consent
Patients with a history of allergy to iodides
Patients history of renal failure or uremia, and those on dialysis

Treatment and study plan

ICG

Drug

Indocyanine green (ICG) is a Food and Drug (FDA)-approved tricarbocyanine dye that is fluorescent under near-infrared (NIR) light. ICG solutions for injection often contain sodium iodide. ICG is water soluble and when introduced intravenously, it is bound by plasma proteins, namely albumin. The intravascular half-life of ICG is 3-4 minutes with rapid hepatic clearance.

Other names: Indocyanine green (ICG)

Primary outcomes

Assessment of ovarian perfusion after ICG administration via fluorescent imaging

Time frame: 2 years

The investigators will be assessing the feasibility of using intravenous ICG to characterize the vascular perfusion of ovaries by imaging. During surgery ICG will be administered intravenously via a peripheral or central line at the direction of the surgeon by the anesthesiologist. The injected amount will be a 3 mL solution of reconstituted ICG that contains a 7.5 mg dose of ICG. This will be followed by a 10 mL bolus of normal saline for injection per the manufacturer's recommendation. The total dose of dye injected should not exceed 2 mg/kg.

Visibility of the ICG fluorescence should occur within 1-2 minutes with a duration of 20-120 minutes.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Intraoperative Use of Intravenous Indocyanine Green (ICG) to Assess Ovarian Perfusion Using Infrared Imaging: A Feasibility Pilot Study

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Apr 25, 2019
Registry last updated: Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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