Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging

NCT01673022 | Completed Results DMC

• 1 other identifier: 1204008493
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 7

Brief Summary

Description: This is a multi-institutional study investigating the sensitivity and negative predictive value of sentinel lymph nodes mapped with robotic assisted near infrared imaging after cervical injection of indocyanine green (ICG) dye for women with stage I endometrial or cervical cancer at the time of their robotic surgical staging. Patients will receive cervical injection of 1mg ICG after induction of anesthesia followed by sentinel lymph node mapping using robotic assisted fluorescence imaging. The sentinel lymph nodes identified will be removed and sent for ultraprocessing by pathology. The non-sentinel pelvic and para-aortic (if indicated) non-sentinel nodes will be removed and sent for routine pathologic processing according to standard of care for these surgical procedures. The pathologic results of the sentinel and non-sentinel nodes will be evaluated for sensitivity and negative predictive value in their ability to detect metastatic disease.

Conditions

Endometrial Cancer; Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Estimate the Sensitivity of the Sentinel Lymph Node

  To estimate the sensitivity of the sentinel lymph node in the determination of lymph node metastases in patients with invasive carcinoma of the cervix and uterus using Indocyanine Green (ICG) and robotic assisted near infrared (NIR) imaging. Sensitivity is defined as the proportion of sentinel lymph node: number of participants with, determined to be metastatic by both IGR/NIR and pathology out of the sentinel lymph nodes found to be metastatic by pathology.

  3 years

Study Arms (1)

IC Green Arm

EXPERIMENTAL

One arm only: Receives IC Green for testing of study objective

Drug: IC Green

Interventions

IC Green DRUG

IC Green

Also known as: indocyanine green for injection, USP

IC Green Arm

Eligibility Criteria

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

You may qualify if:

• Patients must be women 18 years and older who have biopsy proven endometrial or cervical carcinoma (of any histologic subtype).
• Surgical staging with the da Vinci Si robotic tool must be planned with a planned pelvic and, in the case of endometrial cancer, a para-aortic lymphadenectomy
• Patients must meet criteria for robotic surgical approach:
• Patients must have either a clinical stage I endometrial (of any histologic grade) or FIGO stage IA2 or IB1 (\<4cm) cervical squamous, adenocarcinoma or adenosquamous carcinoma.
• Patients must be able to sign an informed consent in English language.
• Patients with known liver disease will require normal range liver function tests as determined by pre-operative labs drawn within 30 days of surgery.

You may not qualify if:

• Patients who have iodide allergies
• Patients who have had previous retroperitoneal surgery
• Patients on whom pelvic+/- para-aortic lymphadenectomy is not planned as part of their surgical staging.
• Patients who have received previous treatment for their endometrial or cervical cancer (particularly hysterectomy or pelvic radiation).
• Patients who are pregnant.
• Patients with documented liver disease who have abnormalities of liver function tests.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (7)

USA Mitchell Cancer Institute

Mobile, Alabama, 36604, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

St. Elizabeth Healthcare

Edgewood, Kentucky, 41017, United States

Location

Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Tri Health Good Smaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• Rossi EC, Kowalski LD, Scalici J, Cantrell L, Schuler K, Hanna RK, Method M, Ade M, Ivanova A, Boggess JF. A comparison of sentinel lymph node biopsy to lymphadenectomy for endometrial cancer staging (FIRES trial): a multicentre, prospective, cohort study. Lancet Oncol. 2017 Mar;18(3):384-392. doi: 10.1016/S1470-2045(17)30068-2. Epub 2017 Feb 1.

  PMID: 28159465 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms; Uterine Cervical Neoplasms

Interventions

Indocyanine Green; Injections

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; Uterine Cervical Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Research Coordinator
• Organization: Indiana University School of Medicine

jmvinter@iupui.edu

317-944-2654

Study Officials

• Emma Rossi, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: August 27, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: July 24, 2018
• Results First Posted: July 24, 2018

Record last verified: 2017-07

Locations

US (7)