This trial is active, not recruiting.

Condition gynecologic cancer
Treatments pet/ct scan, sentinel lymph node mapping
Sponsor M.D. Anderson Cancer Center
Collaborator National Cancer Institute (NCI)
Start date April 2013
End date April 2019
Trial size 150 participants
Trial identifier NCT01737619, 2012-0623, 5 P50 CA098258-08 COEUS 4892, NCI-2015-01898


The goal of this clinical research study is to compare positron emission tomography/computed tomography (PET/CT) scans and sentinel lymph node mapping in finding lymph nodes that have endometrial cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
PET/CT prior to surgery. Surgical approach as determined by the primary surgeon. At time of surgery, an endometrial biopsy will be performed once the patient is under anesthesia. Intra-operative lymphatic mapping with blue dye, radioactive colloid, and/or indocyanine green will be performed. Sentinel lymph nodes will be removed and labeled as blue, green, and/or hot. These nodes will be processed separately.
pet/ct scan Positron Emission Tomography Scan
PET/CT scan before surgery and sentinel lymph node mapping procedure.
sentinel lymph node mapping
Blue dye, a radioactive colloid, and/or an indocyanine green (IC-Green) dye injected into cervix during surgery.

Primary Outcomes

Comparison of PET/CT Versus Sentinel Lymph Node Mapping in Detecting Endometrial Cancer Lymph Nodes
time frame: 1 day

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: 1. Histologically confirmed high grade endometrial cancer including grade 3 endometrioid, serous, clear cell, MMMT or any mixed tumor containing one of these cell types 2. Patients with a grade 1/2 tumors and evidence of deep myometrial invasion or cervical involvement on preoperative imaging or physical exam 3. Candidate for surgery. 4. No evidence of peritoneal disease on preoperative imaging 5. Negative pregnancy test if of child-bearing age 6. No preoperative treatment for endometrial cancer including radiation or chemotherapy 7. Previous hormonal therapy is allowed Exclusion Criteria: 1. Medical co-morbidities making surgery unsafe, as determined by the primary treating physician 2. Any contraindications to PET/CT or lymph node mapping (inability to control serum glucose to a value of

Additional Information

Official title Prospective Evaluation of Lymph Node Metastasis at the Time of Surgical Staging for High Risk Endometrial Cancer
Principal investigator Pamela Soliman, MD
Description If you are found eligible to take part in this study, you will have a PET/CT scan before your surgery and sentinel lymph node mapping procedure during the surgery. For the sentinel lymph node mapping procedure, a blue dye, a radioactive colloid, and/or an indocyanine green (IC-Green) dye will be injected into your cervix during your surgery. The study staff will then use a device that detects radioactivity and that looks for lymph nodes stained with the dye(s). When the study staff locates the sentinel lymph nodes, they will remove them. The sentinel lymph nodes will then be sent to a lab where a pathologist will check them to see if they contain cancer cells. Other lymph nodes may be removed as part of your standard of care surgery if your surgeon thinks it is in your best interest. Length of Study: Your participation in this study will be over after your surgery. This is an investigational study. The 2 procedures being compared in this study are standard of care. Up to 150 participants will be enrolled in this study. Up to 10 will be enrolled at the Harris Health System.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.
Location data was received from the National Cancer Institute and was last updated in June 2016.