PET/CT and Lymph Node Mapping in Finding Lymph Node Metastasis in Patients With High-Risk Endometrial Cancer

Running, not enrolling · Not applicable

Conditions studied: Endometrial Clear Cell Adenocarcinoma, Endometrial Mixed Adenocarcinoma, Endometrial Serous Adenocarcinoma, Grade 3 Endometrial Endometrioid Adenocarcinoma, Malignant Mixed Mesodermal (Mullerian) Tumor

In brief

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.

Key facts

Study ID

NCT01737619

Run by

M.D. Anderson Cancer Center

People needed

101

Starts

2013-04-03

Expected to finish

2028-12-31

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed high grade endometrial cancer including grade 3 endometroid, serous, clear cell, malignant mixed Mullerian tumor (MMMT) or any mixed tumor containing one of these cell types
• Patients with a grade 1/2 tumors and evidence of deep myometrial invasion or cervical involvement on preoperative imaging or physical exam
• Candidate for surgery
• No evidence of peritoneal disease on preoperative imaging
• Negative pregnancy test if of child-bearing age
• No preoperative treatment for endometrial cancer including radiation or chemotherapy
• Previous hormonal therapy is allowed

You may not qualify if…

• Medical co-morbidities making surgery unsafe, as determined by the primary treating physician
• Any contraindications to PET/CT or lymph node mapping (inability to control serum glucose to a value of =< 200 mg/dl for fludeoxyglucose F-18 [FDG]-PET/CT)
• Does not meet histologic criteria
• Evidence of peritoneal or distant metastasis on preoperative imaging
• Baseline creatinine (necessary for imaging studies)

Where it is running

• Lyndon Baines Johnson General Hospital — Houston, Texas, United States
• M D Anderson Cancer Center — Houston, Texas, United States
• The Woman's Hospital of Texas — Houston, Texas, United States
• MD Anderson Regional Care Center-Katy — Houston, Texas, United States
• MD Anderson Regional Care Center-Bay Area — Nassau Bay, Texas, United States
• MD Anderson Regional Care Center-Sugar Land — Sugar Land, Texas, United States
• MD Anderson Regional Care Center-The Woodlands — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

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