ICG to Assess Ovarian Perfusion

Northwestern University

Status and phase: Completed; Early Phase 1

Conditions: Uterine Fibroid; Fibroid Uterus; Uterus Myoma; Endometriosis; Uterine Adenomyosis; Uterine Cyst; Endometrial Cyst

Treatments: Drug: ICG

Study type: Interventional

Funder types: Other

Identifiers

NCT03927651

STU00208846

Details and patient eligibility

About

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

Full 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.

Enrollment: 54 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Administration of ICG

Experimental group

Description:

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.

Treatment:

Drug: ICG