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
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.
Study Type
Interventional
Primary Outcome
Detection of sentinel lymph node(s)
Secondary Outcome
Comparison between sentinel node status for disease and non-sentinel node disease status
Condition
Endometrial Cancer
Intervention
ICG Dye
Study Arms / Comparison Groups
ICG Dye
Description: Patients received injections of Indocyanine green (ICG) for sentinel lymph node (SLN) visualization using near-infrared (NIR) imaging.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
7
Start Date
May 2014
Completion Date
March 8, 2017
Primary Completion Date
March 8, 2017
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
Gender
Female
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Valena Wright, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02131558
Organization ID
2014-017
Responsible Party
Principal Investigator
Study Sponsor
Lahey Clinic
Study Sponsor
Valena Wright, MD, Principal Investigator, Lahey Clinic
Verification Date
August 2020