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

NCT02131558 | Completed

• 1 other identifier: 2014-017
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometrial Cancer; Sentinel Lymph Node Detection

Keywords

Endometrial cancer; Sentinel lymph node; Indocyanine green; Near infrared imaging

Outcome Measures

Primary Outcomes (1)

• Detection of sentinel lymph node(s)

  The primary outcome is to determine whether sentinel lymph nodes (SLN) were accurately visualized using Indocyanine green (ICG) and near-infrared (NIR) imaging.

  Detection of SLNs will occur within surgery, on average this surgery will take "1-2 hours" for each participant

Secondary Outcomes (1)

• Comparison between sentinel node status for disease and non-sentinel node disease status

  Following surgery and pathological evaluation of all removed nodes, up to "1 year"

Study Arms (1)

ICG Dye

EXPERIMENTAL

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

Procedure: ICG Dye

Interventions

ICG Dye PROCEDURE

ICG Dye injections

ICG Dye

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lahey Clinic: lead

Study Sites (1)

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

Location

Related Publications (4)

• 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.

  PMID: 24177256 BACKGROUND

• 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.

  PMID: 21996262 BACKGROUND

• 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. doi: 10.1111/jog.12227.

  PMID: 24620369 BACKGROUND

• 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. doi: 10.6004/jnccn.2014.0026.

  PMID: 24586087 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Valena Wright, MD

  Lahey Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Minimally Invasive Gynecologic Surgery

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: May 6, 2014
• Study Start: May 1, 2014
• Primary Completion: March 8, 2017
• Study Completion: March 8, 2017
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

US (1)