Clinical trial NCT02131558: 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
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Sentinel Lymph Node Detection
Keywords: Endometrial cancer
Sentinel lymph node
Indocyanine green
Near infrared imaging
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Detection of sentinel lymph node(s)
timeFrame: Detection of SLNs will occur within surgery, on average this surgery will take "1-2 hours" for each participant
Secondary outcomes:
measure: Comparison between sentinel node status for disease and non-sentinel node disease status
timeFrame: Following surgery and pathological evaluation of all removed nodes, up to "1 year"
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
Study officials:
affiliation: Lahey Clinic
name: Valena Wright, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.