Sentinel Node Biopsy in Endometrial Cancer

NCT01564264 | Unknown

• 1 other identifier: SNEndometrialCa
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if there is a difference between the lymphatic drainage of the cervix and corpus of the uterus after injecting a radiocolloid in the cervix and blue dye in the corpus of the uterus and to investigate the identification rate of sentinel nodes using this technique in patients with cancer of the uterus.

Conditions

Uterine Neoplasms; Sentinel Lymph Node Biopsy

Keywords

Uterine Neoplasms; Sentinel Lymph Node Biopsy

Outcome Measures

Primary Outcomes (1)

• Location of Sentinel node

  Locations: internal iliac, external iliac, common iliac, paraaortic or presacral areas Location will be registered by type of sentinel nodes: blue nodes, reflecting the uterine pattern of lymphatic flow (after myometrial injection of blue dye)and hot nodes, reflecting cervical pattern of lymphatic flow (after injection of Technetium 99 in the cervix)

  Measurement for each participant will be performed between 2-4 hours after injecting Technetium 99 in the cervix

Secondary Outcomes (1)

• Identification of metastatic lymph nodes by the sentinel node procedure

  Measurement will be performed 2-4 hours after the cervical injection with Technetium 99

Study Arms (1)

Sentinel Node Biopsy

EXPERIMENTAL

Each participant will have both measurements, the new diagnostic test (sentinel node biopsy) and the gold standard (complete lymphadenectomy)

Procedure: Sentinel Lymph Node Biopsy

Interventions

Sentinel Lymph Node Biopsy PROCEDURE

Sentinel node biopsy after injections of 0.4 mci of Technetium 99 in the cervix and 4 mL of Patent Blue into the myometrium followed by standard retroperitoneal lymph node dissection

Sentinel Node Biopsy

Eligibility Criteria

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

You may qualify if:

• Women older than 18 years old
• Endometrial cancer
• Histologies: Grade 2 and 3 endometrioid adenocarcinoma, clear cell and papillary serous carcinoma
• Suitable candidates for surgery
• Clinically stage 1 or confined to the uterus

You may not qualify if:

• Grade 1 endometrioid adenocarcinoma
• Metastatic disease

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Juravinski Cancer Centre Foundation: collaborator

Study Sites (1)

Juravinski Hospital, Juravinski Cancer Centre, McMaster University

Hamilton, Ontario, L8V 5C2, Canada

RECRUITING

MeSH Terms

Conditions

Uterine Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

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)

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

Study Officials

• Waldo G Jimenez, MD MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Waldo G Jimenez, MD MSc

CONTACT

(905) 389-5688; Waldo.Jimenez@jcc.hhsc.ca

Laurie Elit, MD MSc

CONTACT

(905) 389-5688; Laurie.Elit@jcc.hhsc.ca

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: March 23, 2012
• First Posted: March 27, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 3, 2014

Record last verified: 2014-08

Locations

CA (1)