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

• Status: Active, not recruiting
• Trial end date: 2025-04-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)