ICG to Assess Ovarian Perfusion
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|ClinicalTrials.gov Identifier: NCT03927651|
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : September 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Fibroid Uterus Endometriosis Uterus Myoma Uterine Fibroid Uterine Adenomyosis Endometrial Cyst Uterine Cyst||Drug: ICG||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intraoperative Use of Intravenous Indocyanine Green (ICG) to Assess Ovarian Perfusion Using Infrared Imaging: A Feasibility Pilot Study|
|Actual Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||December 8, 2020|
|Estimated Study Completion Date :||April 2021|
Experimental: Administration of ICG
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. ICG will be stored at the NM Investigational Pharmacy and administered intravenously by the anesthesiologist at the direction of the surgeon during surgical procedure.
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 Name: Indocyanine green (ICG)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927651
|Contact: Jeremy W Cornelius, MSemail@example.com|
|United States, Illinois|
|259 E Erie - Northwestern||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Magdy Milad firstname.lastname@example.org|
|Principal Investigator:||Magdy Milad, MD,MS||Northwestern University|