ICG to Assess Ovarian Perfusion

NCT03927651 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: STU00208846
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Assessment of ovarian perfusion after ICG administration via fluorescent imaging

  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.

  2 years

Study Arms (1)

Administration of ICG

EXPERIMENTAL

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.

Drug: ICG

Interventions

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.

Also known as: Indocyanine green (ICG)

Administration of ICG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

259 E Erie - Northwestern

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Leiomyoma; Endometriosis; Myofibroma; Adenomyosis

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Connective Tissue; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Uterine Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Magdy Milad, MD,MS

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Minimally Invasive Gynecologic Surgery in the Department of Obstetrics and Gynecology Albert B. Gerbie, MD, Professor of Obstetrics and Gynecology Professor of Obstetrics and Gynecology (Minimally Invasive Gynecologic Surgery)

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 25, 2019
• Study Start: June 1, 2019
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

US (1)