NCT02068820

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

September 10, 2019

Completed
Last Updated

September 10, 2019

Status Verified

August 1, 2019

Enrollment Period

2.3 years

First QC Date

February 14, 2014

Results QC Date

December 18, 2017

Last Update Submit

August 20, 2019

Conditions

Endometrial Cancer

Keywords

Sentinel lymph nodesda VinciFireflySentinel lymph node mappingFluorescence ImagingSLNSLN mapping

Outcome Measures

Primary Outcomes (1)

  • Number of Pelvic Sentinel Lymph Nodes (SLN) in Endometrial Cancer Patients Detected by Either ICG and/or ISB Dyes.

    through 6 weeks post-operative

Secondary Outcomes (1)

  • Negative Predictive Value (NPV) of Pelvic SLN in Endometrial Cancer in Relation to the Number of Nodes With Metastasis.

    through 6 weeks post-operative

Other Outcomes (1)

  • Number of Pelvic Sentinal Lymph Nodal Metastasis in Regard to Staining by Immunohistochemical (IHC) Staining in Comparison to Standard Hematoxylin and Eosin (H&E).

    through 6 weeks post-operative

Study Arms (2)

ISB dye, standard white light

ACTIVE COMPARATOR

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

Device: ISB dye and standard white light imaging

ICG dye, FireFly fluorescence imaging

EXPERIMENTAL

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.

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

Interventions

ISB dye and standard white light imagingDEVICE

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

Also known as: Isosulfan Blue dye
ICG dye, FireFly fluorescence imagingISB dye, standard white light
ICG dye and FireFly fluorescence imagingDEVICE

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

Also known as: Indocyanine green dye
ICG dye, FireFly fluorescence imaging

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • The patient is not a candidate for robotic assisted hysterectomy and lymphadenectomy.
  • The patient has known or suspected allergies to iodine, ICG or ISB.
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Hospital Gynecologic Oncology

Orlando, Florida, 32804, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Results Point of Contact

Title
Robert W. Holloway
Organization
Florida Hospital Gynecologic Oncology
robhollowaymd@gmail.com
407-303-2400

Study Officials

  • Robert Holloway, MD

    Florida Hospital Gynecologic Oncology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2014

First Posted

February 21, 2014

Study Start

September 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

September 10, 2019

Results First Posted

September 10, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)