Indocyanine Green and Near-infrared Fluorescence Imaging to Detect Sentinel Lymph Nodes in Patients With Endometrial Cancer

Overview

Patients with endometrial cancer who have planned robotic laparoscopic hysterectomy and full bilateral pelvic and para-aortic lymphadenectomy will receive injections of a fluorescent dye, Indocyanine green (ICG). ICG spreads through the lymphatic system, and will be visualized using near-infrared (NIR) imagers. Upon visualization of the path of the ICG, sentinel lymph nodes (SLNs), the first nodes to receive drainage from the primary tumor, will be identified. SLNs will be surgically removed and provided to Pathology for evaluation. Non-sentinel nodes will also be surgically removed, as is consistent with routine medical care for these patients, and given to Pathology for evaluation. A positive SLN may be the most accurate identifier of the extra-uterine spread of disease, and will provide information about the extent of surgical node removal necessary.

Full Title of Study: “The Feasibility and Benefits of Using Indocyanine Green and Near-infrared Fluorescence Imaging to Detect Sentinel Lymph Nodes in Patients With Endometrial Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2015

Interventions

  • Procedure: ICG Dye
    • ICG Dye injections

Arms, Groups and Cohorts

  • Experimental: ICG Dye
    • Patients received injections of Indocyanine green (ICG) for sentinel lymph node (SLN) visualization using near-infrared (NIR) imaging.

Clinical Trial Outcome Measures

Primary Measures

  • Detection of sentinel lymph node(s)
    • Time Frame: Detection of SLNs will occur within surgery, on average this surgery will take “1-2 hours” for each participant
    • The primary outcome is to determine whether sentinel lymph nodes (SLN) were accurately visualized using Indocyanine green (ICG) and near-infrared (NIR) imaging.

Secondary Measures

  • Comparison between sentinel node status for disease and non-sentinel node disease status
    • Time Frame: Following surgery and pathological evaluation of all removed nodes, up to “1 year”
    • The pathological evaluation of the sentinel lymph nodes (positive or negative) will be compared to the status of the non-sentinel nodes removed to determine whether the sentinel nodes accurately reflected the same status as the non-sentinel nodes.

Participating in This Clinical Trial

Inclusion Criteria

  • Adult women patients (>18 years of age and <90 years of age)
  • Research authorization (consent)
  • Pre-operative diagnosis of clinical Stage 1 endometrial cancer
  • Pre-operative indications of grade 3 tumor, and/or tumor size greater than 2 cm in size
  • Scheduled and consented to undergo robotic hysterectomy and surgical staging, including bilateral pelvic and para-aortic lymphadenectomy

Exclusion Criteria

  • Severe coagulopathy or severe thrombocytopenia
  • Severe anemia
  • Severe cardio-pulmonary comorbidities demanding minimization of operative time
  • History of liver disease
  • Iodide allergy
  • Emergent operation
  • Additional surgical risk as determined during surgery at the discretion of the attending
  • Impaired capacity to make informed medical decisions

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lahey Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Valena Wright, Director of Minimally Invasive Gynecologic Surgery – Lahey Clinic
  • Overall Official(s)
    • Valena Wright, MD, Principal Investigator, Lahey Clinic

References

Rossi EC, Jackson A, Ivanova A, Boggess JF. Detection of sentinel nodes for endometrial cancer with robotic assisted fluorescence imaging: cervical versus hysteroscopic injection. Int J Gynecol Cancer. 2013 Nov;23(9):1704-11. doi: 10.1097/IGC.0b013e3182a616f6.

Rossi EC, Ivanova A, Boggess JF. Robotically assisted fluorescence-guided lymph node mapping with ICG for gynecologic malignancies: a feasibility study. Gynecol Oncol. 2012 Jan;124(1):78-82. doi: 10.1016/j.ygyno.2011.09.025. Epub 2011 Oct 11.

Abu-Rustum NR. Update on sentinel node mapping in uterine cancer: 10-year experience at Memorial Sloan-Kettering Cancer Center. J Obstet Gynaecol Res. 2014 Feb;40(2):327-34.

Abu-Rustum NR. Sentinel lymph node mapping for endometrial cancer: a modern approach to surgical staging. J Natl Compr Canc Netw. 2014 Feb;12(2):288-97. Review.

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