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

PRIMARY OBJECTIVES:

I. To estimate the false negative rate of PET/CT and/or sentinel lymph node mapping in the
detection of positive lymph nodes in women with high risk endometrial cancers.

SECONDARY OBJECTIVES:

I. To estimate the sensitivity, specificity, positive predictive value, and negative
predictive value of PET/CT and/or sentinel lymph node mapping in the detection of positive
lymph nodes in women with high risk endometrial cancer.

II. To determine if a molecular panel of estrogen-induced genes that we have previously
identified from retrospective studies correlate with extra-uterine spread including lymph
node metastasis at the time of surgical staging for endometrial cancer.

III. To prospectively identify patterns of lymphatic spread of endometrial cancer.

IV. To correlate cancer antigen 125 (CA-125) and WAP four-disulfide core domain 2 (HE4)
levels with disease metastasis at the time of surgical staging and to explore the use of
other serum biomarkers to predict recurrence.

V. To prospectively collect morbidity and mortality data related to performing lymph node
dissection including intra-operative and postoperative complications.

VI. To determine whether metabolic parameters of the primary endometrial tumor on PET
including tumor intensity (maximum standard uptake value [SUV] and peak SUV), metabolic tumor
volume (obtained at a threshold of 40% of maximum and at a threshold of SUV=3), and total
lesion glycolysis (expressed average SUV over the metabolic tumor volume) are predictive of
locoregional or metastatic spread, and whether these parameters correlate with CA-125 and HE4
levels.

OUTLINE:

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.

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)