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

Primary Purpose

Endometrial Cancer, Sentinel Lymph Node Detection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ICG Dye
Sponsored by
Lahey Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometrial Cancer focused on measuring Endometrial cancer, Sentinel lymph node, Indocyanine green, Near infrared imaging

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Lahey Hospital & Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICG Dye

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 7, 2014
Last Updated
August 31, 2020
Sponsor
Lahey Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02131558
Brief Title
Indocyanine Green and Near-infrared Fluorescence Imaging to Detect Sentinel Lymph Nodes in Patients With Endometrial Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 8, 2017 (Actual)
Study Completion Date
March 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lahey Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer, Sentinel Lymph Node Detection
Keywords
Endometrial cancer, Sentinel lymph node, Indocyanine green, Near infrared imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICG Dye
Arm Type
Experimental
Arm Description
Patients received injections of Indocyanine green (ICG) for sentinel lymph node (SLN) visualization using near-infrared (NIR) imaging.
Intervention Type
Procedure
Intervention Name(s)
ICG Dye
Intervention Description
ICG Dye injections
Primary Outcome Measure Information:
Title
Detection of sentinel lymph node(s)
Description
The primary outcome is to determine whether sentinel lymph nodes (SLN) were accurately visualized using Indocyanine green (ICG) and near-infrared (NIR) imaging.
Time Frame
Detection of SLNs will occur within surgery, on average this surgery will take "1-2 hours" for each participant
Secondary Outcome Measure Information:
Title
Comparison between sentinel node status for disease and non-sentinel node disease status
Description
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.
Time Frame
Following surgery and pathological evaluation of all removed nodes, up to "1 year"

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valena Wright, MD
Organizational Affiliation
Lahey Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lahey Hospital & Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24177256
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.
Results Reference
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PubMed Identifier
21996262
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.
Results Reference
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PubMed Identifier
24620369
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. doi: 10.1111/jog.12227.
Results Reference
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PubMed Identifier
24586087
Citation
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.
Results Reference
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Indocyanine Green and Near-infrared Fluorescence Imaging to Detect Sentinel Lymph Nodes in Patients With Endometrial Cancer

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