Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG

AdventHealth

Status: Completed

Conditions: Endometrial Cancer

Treatments: Device: ISB dye and standard white light imaging; Device: ICG dye and FireFly fluorescence imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02068820

SLN Mapping

Details and patient eligibility

About

The investigators hypothesis is that if sensitivity and specificity are found to be significantly higher than the current reports with Technesium-99 and ISB colorimetric dye, SLN biopsies might allow omission of full lymphadenectomy in lower-risk cases, thereby limiting peri-operative morbidity. SLN biopsies might also improve the detection of metastatic disease, essentially lowering the recognized false-negative rate of standard lymphadenectomy analyzed by routine H&E pathologic analysis.

Full description

The study objective is to compare two sentinel lymph node detection technologies [fluorescence imaging and Indocyanine Green (ICG) dye verses standard laparoscopic colorimetric analysis using Isosulfan Blue (ISB) dye] for sensitivity and specificity of detecting metastatic disease in pelvic lymph nodes of women with endometrial cancer undergoing robotic-assisted laparoscopic hysterectomy and lymphadenectomy. The following three specific aims would be addressed in this research proposal:

Specific Aim 1: To determine the ability of mapping bilaterally pelvic SLN in women with endometrial cancer undergoing robotic-assisted laparoscopic staging comparing two different methods (i.e., comparing the combination of colorimetric analysis-ISB dye + fluorescence imaging-ICG dye vs. colorimetric analysis-ISB dye alone).

Specific Aim 2: To estimate the negative predictive value (NPV) of pelvic SLN in endometrial cancer with respect to predicting nodal metastasis.

Specific Aim 3: To evaluate the ability of sentinel lymph nodes to increase the detection of metastatic disease through ultra-sectioning and immuno-histochemical (IHC) staining by comparing IHC results and standard hematoxylin and eosin (H&E) results.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient must be ≥18 and ≤85 years of age.
2. The patient must be female.
3. The patient must be willing and able to provide informed consent.
4. The patient is willing and able to comply with the study protocol.
5. The patient has endometrial cancer and is scheduled for robotic hysterectomy and lymphadenectomy.
6. The patient agrees to follow-up examinations out to 6-weeks post-treatment

Exclusion criteria

1. The patient is not a candidate for robotic assisted hysterectomy and lymphadenectomy.
2. The patient has known or suspected allergies to iodine, ICG or ISB.
3. The patient has hepatic dysfunction confirmed by elevated liver function studies (i.e., hepatic enzyme SGOT, SGPT or Bilirubin > 2 x normal (based on reference values from the laboratory used by the patient)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

ISB dye, standard white light

Active Comparator group

Description:

SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging.

Treatment:

Device: ISB dye and standard white light imaging

ICG dye, FireFly fluorescence imaging

Experimental group

Description:

SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging.

Treatment:

Device: ICG dye and FireFly fluorescence imaging

Device: ISB dye and standard white light imaging