Lymph Node Mapping in Patients With Endometrial Cancer

NCT01818739 | Completed Results DMC

• 2 other identifiers: OSU-12114NCI-2013-00530
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 2

Brief Summary

This clinical trial studies lymph node mapping in patients with endometrial cancer. Lymph node mapping may allow for limited removal of lymph nodes in as part of endometrial cancer staging and treatment.

Conditions

Endometrial Cancer

Keywords

Endometrial Cancer; Robotic-Assisted Staging

Outcome Measures

Primary Outcomes (1)

• Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease

  NPV is found by dividing the number of true negatives by the number of all patients without pelvic lymph node metastases. Exact 95% confidence intervals (CIs) for the proportions will be calculated.

  average of 1-14 days after the procedure when final pathologic evaluation has been completed

Secondary Outcomes (1)

• Percentage of Metastatic Cases Found Using Ultra-sectioning and IHC Staining

  average of 1-14 days after the procedure when final pathologic evalulation has been completed

Study Arms (1)

sentinel lymph node detection

EXPERIMENTAL

Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.

Procedure: sentinel lymph node detection; Drug: indocyanine green solution; Drug: isosulfan blue; Procedure: sentinel lymph node biopsy

Interventions

sentinel lymph node detection PROCEDURE

Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue

sentinel lymph node detection

indocyanine green solution DRUG

Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue

Also known as: IC-GREEN, ICG solution

sentinel lymph node detection

isosulfan blue DRUG

Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue

Also known as: Lymphazurin, N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide

sentinel lymph node detection

sentinel lymph node biopsy PROCEDURE

Undergo sentinel lymph node biopsy

Also known as: sentinel node biopsy

sentinel lymph node detection

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 5-years 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, indocyanine green (ICG) or isosulfan blue (ISB)
• The patient has hepatic dysfunction confirmed by bilirubin \> 2 x normal (based on reference values from the laboratory used by the patient)

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (2)

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, 06520, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Backes FJ, Cohen D, Salani R, Cohn DE, O'Malley DM, Fanning E, Suarez AA, Fowler JM. Prospective clinical trial of robotic sentinel lymph node assessment with isosulfane blue (ISB) and indocyanine green (ICG) in endometrial cancer and the impact of ultrastaging (NCT01818739). Gynecol Oncol. 2019 Jun;153(3):496-499. doi: 10.1016/j.ygyno.2019.03.252. Epub 2019 Apr 4.

  PMID: 31230614 BACKGROUND

Related Links

• The Jamesline

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Indocyanine Green; iso-sulfan blue; Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Results Point of Contact

• Title: Floor Backes, MD
• Organization: The Ohio State University Comprehensive Cancer Center

Floor.Backes@osumc.edu

614-730-6968

Study Officials

• Floor Backes, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: March 26, 2013
• Study Start: March 1, 2013
• Primary Completion: November 16, 2016
• Study Completion: March 31, 2017
• Last Updated: March 22, 2023
• Results First Posted: June 22, 2021

Record last verified: 2023-03

Locations

US (2)