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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
Sponsor:
Information provided by (Responsible Party):
Magdy Milad, MD, Northwestern University

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

Condition or disease Intervention/treatment Phase
Fibroid Uterus Endometriosis Uterus Myoma Uterine Fibroid Uterine Adenomyosis Endometrial Cyst Uterine Cyst Drug: ICG 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
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 1, 2019
Estimated Primary Completion Date : December 8, 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


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.
Other Name: Indocyanine green (ICG)




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.




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Ages Eligible for Study:   18 Years 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927651


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

Locations
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United States, Illinois
259 E Erie - Northwestern Recruiting
Chicago, Illinois, United States, 60611
Contact: Magdy Milad       milad@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Magdy Milad, MD,MS Northwestern University
  Study Documents (Full-Text)

Documents provided by Magdy Milad, MD, Northwestern University:
Study Protocol  [PDF] June 8, 2020
Informed Consent Form  [PDF] June 8, 2020

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Responsible Party: Magdy Milad, MD, 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), Northwestern University
ClinicalTrials.gov Identifier: NCT03927651    
Other Study ID Numbers: STU00208846
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020

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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:
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Leiomyoma
Myofibroma
Cysts
Endometriosis
Adenomyosis
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Pathological Conditions, Anatomical
Uterine Diseases