Brief Summary

This clinical trial studies positron emission tomography (PET)/computed tomography (CT) and lymph node mapping in finding lymph node metastasis in patients with endometrial cancer that is at high risk of spreading. A PET/CT scan is a procedure that combines the pictures from a PET scan and a CT scan, which are taken at the same time from the same machine. The combined scans give more detailed pictures of areas inside the body than either scan gives by itself. Lymph node mapping uses a radioactive dye, called indocyanine green solution, to identify lymph nodes that may contain cancer cells. PET/CT and sentinel lymph node mapping may be better ways than surgery to identify cancer in the lymph nodes.

Trial Health

On Track

Trial Health Score

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

Enrollment

101

participants targeted

Target at P50-P75 for not_applicable

Timeline

33mo left

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach

1 country

7 active sites

Status

active not recruiting

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

15.8 years study duration

Study Progress83%

Apr 2013Dec 2028

First Submitted

Initial submission to the registry

November 27, 2012

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed

4 months until next milestone

Study Start

First participant enrolled

April 3, 2013

Completed

12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed

7 months until next milestone

Results Posted

Study results publicly available

November 28, 2025

Completed

3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Expected

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

12.1 years

First QC Date

November 27, 2012

Results QC Date

October 21, 2025

Last Update Submit

April 20, 2026

Conditions

Endometrial Clear Cell Adenocarcinoma Endometrial Mixed Adenocarcinoma Endometrial Serous Adenocarcinoma Grade 3 Endometrial Endometrioid Adenocarcinoma Malignant Mixed Mesodermal (Mullerian) Tumor

Outcome Measures

Primary Outcomes (1)

False Negative Rate of PET/CT Verses Sentinel Lymph Node Mapping in the Detection of Positive Lymph Nodes in Women With High Risk Endometrial Cancers.
36 months

Secondary Outcomes (2)

False Negative Rate and False Negative Predictive Values of Lymphatic Spread of Endometrial Spread of Endometrial Lymph Nodes From a PET/CT Versus Lymphatic Mapping Procedure
36 months
Mortality Rate of Patients Undergoing Lymph Node Dissection Including Intra-operative and Postoperative Complications
36 months

Study Arms (1)

Diagnostic (PET/CT, lymph node mapping)

EXPERIMENTAL

Patients undergo PET/CT prior to surgery. Patients then undergo intraoperative lymph node mapping with indocyanine green solution, given via superficial and deep cervical injection during full lymphadenectomy.

Procedure: Computed TomographyDrug: Indocyanine Green SolutionOther: Laboratory Biomarker AnalysisProcedure: Lymph Node MappingProcedure: LymphadenectomyProcedure: Positron Emission Tomography

Interventions

Computed TomographyPROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography