ICG to Assess Ovarian Perfusion

Early Phase 1

Completed

• Conditions: Fibroid Uterus; Endometriosis; Uterine Fibroid; Uterus Myoma; Uterine Adenomyosis; Endometrial Cyst; Uterine Cyst
• Interventions: Drug: ICG

• Registration Number: NCT03927651
• Lead Sponsor: Northwestern University

Brief Summary

To assess the feasibility of using intravenous ICG to characterize the vascular perfusion of ovaries during gynecologic surgery

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-24
• Study First Posted: 2019-04-25
• Study Start: 2019-06-01
• Primary Completion: 2022-11-15
• Study Completion: 2022-11-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Administration of ICG	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.

Primary Outcome Measures

Name	Time	Method
Assessment of ovarian perfusion after ICG administration via fluorescent imaging	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.

Trial Locations

Locations (1)

259 E Erie - Northwestern; 🇺🇸 Chicago, Illinois, United States