Clinical trial NCT01737619: PET/CT and Lymph Node Mapping in Finding Lymph Node Metastasis in Patients With High-Risk Endometrial Cancer
Official title: Prospective Evaluation of Lymph Node Metastasis at the Time of Surgical Staging for High Risk Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Endometrial Clear Cell Adenocarcinoma
Endometrial Mixed Adenocarcinoma
Endometrial Serous Adenocarcinoma
Grade 3 Endometrial Endometrioid Adenocarcinoma
Malignant Mixed Mesodermal (Mullerian) Tumor
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-11-29
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: 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.

Eligibility 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)

Primary outcomes:
measure: False negative rate of positron emission tomography (PET)/computed tomography (CT)
timeFrame: Baseline
measure: False negative rate of sentinel lymph node mapping
timeFrame: At time of surgery
Secondary outcomes:
measure: Concordance for each procedure and for the combination of both procedures
timeFrame: At time of surgery
measure: Sensitivity of each procedure and for the combination of both procedures
timeFrame: At time of surgery
measure: Specificity of each procedure and for the combination of both procedures
timeFrame: At time of surgery
measure: Positive predictive value (PPV) of each procedure and for the combination of both procedures
timeFrame: At time of surgery
measure: Negative predictive value (NPV) of each procedure and for the combination of both procedures
timeFrame: At time of surgery
measure: CA-125 levels
timeFrame: Baseline
measure: HE4 levels
timeFrame: Baseline
measure: Metabolic parameters
timeFrame: Baseline
measure: Incidence of intra-operative complications
timeFrame: At time of surgery
measure: Incidence of post-operative complications
timeFrame: At time of surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon Baines Johnson General Hospital
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: The Woman's Hospital of Texas
state: Texas
city: Houston
country: United States
facility: MD Anderson Regional Care Center-Katy
state: Texas
city: Nassau Bay
country: United States
facility: MD Anderson Regional Care Center-Bay Area
state: Texas
city: Sugar Land
country: United States
facility: MD Anderson Regional Care Center-Sugar Land
state: Texas
city: The Woodlands
country: United States
facility: MD Anderson Regional Care Center-The Woodlands
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Pamela Soliman
role: PRINCIPAL_INVESTIGATOR
References: