NCT00671606

Brief Summary

The goal of this clinical research study is to learn if a procedure called intraoperative (during surgery) lymphatic mapping can be used to find the sentinel lymph node in patients with endometrial cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

2 active sites

Status
terminated

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

April 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 5, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 27, 2011

Completed
Last Updated

May 27, 2016

Status Verified

April 1, 2012

Enrollment Period

2.2 years

First QC Date

April 29, 2008

Results QC Date

June 30, 2011

Last Update Submit

April 29, 2016

Conditions

Endometrial Cancer

Keywords

Endometrial CancerLymphatic MappingSentinel Node IdentificationLymph NodeIntraoperative lymphatic mappingTotal hysterectomyBilateral salpingooophorectomyLymph node stagingLaparotomyLaparoscopy

Outcome Measures

Primary Outcomes (1)

  • Sentinel Node Identification Rate

    Feasibility of sentinel node identification rate using intraoperative hysteroscopic injection of patent blue dye and radiocolloid for the detection of sentinel lymph nodes in patients with endometrial cancer. Sentinel node identification before and during surgery using a gamma counter to identify lymph nodes that have absorbed Tc-99m sulfur colloid. Study feasibility assessed with enrollment of 20 participants, approximately 1 year.

    15-20 minute procedure prior to/during routine surgery for identifying the sentinel nodes

Study Arms (1)

Intraoperative Lymphatic Mapping

EXPERIMENTAL

Intraoperative sentinel lymph node identification (lymphatic mapping)

Procedure: Intraoperative Lymphatic Mapping

Interventions

Intraoperative Lymphatic MappingPROCEDURE

Intraoperative hysteroscopic injection of patent blue dye and radiocolloid for detection of sentinel lymph nodes.

Intraoperative Lymphatic Mapping

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with biopsy confirmed endometrial cancer who have been dispositioned to undergo total hysterectomy, bilateral salpingooophorectomy and lymph node staging.
  • Surgical procedures may be performed by either laparotomy or laparoscopy.
  • If computed tomography, magnetic resonance imaging, lymphangiography, or ultrasound has been performed for preoperative assessment, there must be no evidence of metastases. Imaging is not mandatory.
  • Patients who have signed an approved informed consent and authorization permitting release of personal health information.

You may not qualify if:

  • Patients with a preoperative diagnosis of grade I endometrioid adenocarcinoma of the uterus.
  • Patients with uterine papillary serous carcinoma.
  • Patients who have undergone endometrial ablation or a myomectomy within 1 year of the surgery for endometrial cancer.
  • Patients with known allergies to triphenylmethane compounds or technetium-99 radiocolloid.
  • Patients with a history of retroperitoneal surgery.
  • Patients with a history of pelvic radiation.
  • Patients with no lesion visible on hysteroscopy.
  • Patients with previous exposure to the tracer (to prevent risk of allergic reaction).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

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

Limitations and Caveats

Early termination due to low detection rate of sentinel lymph nodes in the five participants.

Results Point of Contact

Title
Dr. Michael Frumovitz, ND/Assistant Professor
Organization
UT MD Anderson Cancer Center
tjohnsto@mdanderson.org

Study Officials

  • Michael M. Frumovitz, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2008

First Posted

May 5, 2008

Study Start

April 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

May 27, 2016

Results First Posted

July 27, 2011

Record last verified: 2012-04

Locations

US(2)