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NCT Number: NCT02131558

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

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.

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Sentinel Lymph Node Detection Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICG Dye

Procedure

ICG Dye injections

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Lahey Clinic

Other

Registry information

Official study title

The Feasibility and Benefits of Using Indocyanine Green and Near-infrared Fluorescence Imaging to Detect Sentinel Lymph Nodes in Patients With Endometrial Cancer

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 6, 2014
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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