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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.

ICG to Assess Ovarian Perfusion

Clinicaltrials.gov identifier NCT03927651

Recruitment Status Recruiting

First Posted April 25, 2019

Last update posted September 24, 2020

Study Description

Brief summary:

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

  • Condition or Disease:Fibroid Uterus
    Endometriosis
    Uterus Myoma
    Uterine Fibroid
    Uterine Adenomyosis
    Endometrial Cyst
    Uterine Cyst
  • Intervention/Treatment: Drug: ICG
  • Phase: Early Phase 1
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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 30 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Diagnostic
  • 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 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: April 2021
Arms and interventions
Arm Intervention/treatment
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.
Drug: ICG
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.
Outcome Measures
  • Primary Outcome Measures: 1. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 50 Years (Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: Yes
Criteria

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

Contacts and Locations
Contacts

Contact: Jeremy W Cornelius, MS 224-258-7960 jeremy.cornelius@nm.org

Locations

United States, Illinois
259 E Erie - Northwestern
Chicago

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator: Magdy Milad, MD,MS Northwestern University

More Information
  • Responsible Party: Northwestern University
  • ClinicalTrials.gov Identifier: NCT03927651 History of Changes
  • Other Study ID Numbers: STU00208846
  • First Posted: April 25, 2019 Key Record Dates
  • Last Update Posted: September 24, 2020
  • Last Verified: September 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Leiomyoma
    Myofibroma
    Cysts
    Endometriosis
    Adenomyosis