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

NCT ID: NCT02068820

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-01-31

Brief Summary

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.

Detailed 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.

Conditions

Endometrial Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ISB dye, standard white light

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

Group Type: ACTIVE_COMPARATOR

ISB dye and standard white light imaging

Intervention Type: DEVICE

Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.

ICG dye, FireFly fluorescence imaging

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.

Group Type: EXPERIMENTAL

ISB dye and standard white light imaging

Intervention Type: DEVICE

Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.

ICG dye and FireFly fluorescence imaging

Intervention Type: DEVICE

Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging.

Interventions

ISB dye and standard white light imaging

Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.

Intervention Type: DEVICE

ICG dye and FireFly fluorescence imaging

Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging.

Intervention Type: DEVICE

Other Intervention Names

Isosulfan Blue dye; Indocyanine green dye

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AdventHealth

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Holloway, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Hospital Gynecologic Oncology

Locations

Florida Hospital Gynecologic Oncology

Orlando, Florida, United States

Countries

United States

Other Identifiers

SLN Mapping

Identifier Type: -

Identifier Source: org_study_id