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

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02131558
• Other study ID #: 2014-017
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: March 8, 2017

Study information

• Verified date: August 2020
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: March 8, 2017
• Est. primary completion date: March 8, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Sentinel Lymph Node Detection

Intervention

Procedure:
• ICG Dye
ICG Dye injections

Locations

Country	Name	City	State
United States	Lahey Hospital & Medical Center	Burlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Lahey Clinic

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison between sentinel node status for disease and non-sentinel node disease status	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.	Following surgery and pathological evaluation of all removed nodes, up to "1 year"