Endometrial Clear Cell Adenocarcinoma, Endometrial Mixed Adenocarcinoma, Endometrial Serous Adenocarcinoma, Grade 3 Endometrial Endometrioid Adenocarcinoma, Malignant Mixed Mesodermal (Mullerian) Tumor
Conditions
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.
Interventions
PROCEDUREComputed Tomography
Undergo PET/CT
Given via superficial and deep cervical injection
OTHERLaboratory Biomarker Analysis
Correlative studies
PROCEDURELymph Node Mapping
Undergo lymph node mapping
PROCEDURELymphadenectomy
Undergo full lymphadenectomy
PROCEDUREPositron Emission Tomography
Undergo PET/CT
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| False Negative Rate of PET/CT Verses Sentinel Lymph Node Mapping in the Detection of Positive Lymph Nodes in Women With High Risk Endometrial Cancers. | 36 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| False Negative Rate and False Negative Predictive Values of Lymphatic Spread of Endometrial Spread of Endometrial Lymph Nodes From a PET/CT Versus Lymphatic Mapping Procedure | 36 months | — |
| Mortality Rate of Patients Undergoing Lymph Node Dissection Including Intra-operative and Postoperative Complications | 36 months | Mortality percentage of patients following the lymph node mapping procedure and postoperative complications. |
Countries
United States
Participant flow
Recruitment details
The trial was active from April 2013 until May 2016 and all recruitments were done in a medical clinic setting.
Participants by arm
| Arm | Count |
|---|---|
| Sentinel Node Mapping Pre-op PET/CT scan followed by intraoperative sentinel lymph node mapping and biopsy then complete pelvic and para-aortic lymphadenectomy | 101 |
| Total | 101 |
Baseline characteristics
| Characteristic | Sentinel Node Mapping |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 37 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants |
| Age, Continuous | 62 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants |
| Race (NIH/OMB) White | 63 Participants |
| Region of Enrollment United States | 101 participants |
| Sex: Female, Male Female | 101 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 101 |
| other Total, other adverse events | 0 / 101 |
| serious Total, serious adverse events | 0 / 101 |
Outcome results
Primary
False Negative Rate of PET/CT Verses Sentinel Lymph Node Mapping in the Detection of Positive Lymph Nodes in Women With High Risk Endometrial Cancers.
Time frame: 36 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sentinel Node Mapping | False Negative Rate of PET/CT Verses Sentinel Lymph Node Mapping in the Detection of Positive Lymph Nodes in Women With High Risk Endometrial Cancers. | , sensitivity of sentinel lymph node mapping | 95 percentage |
| Sentinel Node Mapping | False Negative Rate of PET/CT Verses Sentinel Lymph Node Mapping in the Detection of Positive Lymph Nodes in Women With High Risk Endometrial Cancers. | false negative rate | 5 percentage |
| Sentinel Node Mapping | False Negative Rate of PET/CT Verses Sentinel Lymph Node Mapping in the Detection of Positive Lymph Nodes in Women With High Risk Endometrial Cancers. | false negative predictive value | 1.4 percentage |
Secondary
False Negative Rate and False Negative Predictive Values of Lymphatic Spread of Endometrial Spread of Endometrial Lymph Nodes From a PET/CT Versus Lymphatic Mapping Procedure
Time frame: 36 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sentinel Node Mapping | False Negative Rate and False Negative Predictive Values of Lymphatic Spread of Endometrial Spread of Endometrial Lymph Nodes From a PET/CT Versus Lymphatic Mapping Procedure | false negative rate | 4.3 percentage |
| Sentinel Node Mapping | False Negative Rate and False Negative Predictive Values of Lymphatic Spread of Endometrial Spread of Endometrial Lymph Nodes From a PET/CT Versus Lymphatic Mapping Procedure | false negative predictive value | 1.4 percentage |
Secondary
Mortality Rate of Patients Undergoing Lymph Node Dissection Including Intra-operative and Postoperative Complications
Mortality percentage of patients following the lymph node mapping procedure and postoperative complications.
Time frame: 36 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sentinel Node Mapping | Mortality Rate of Patients Undergoing Lymph Node Dissection Including Intra-operative and Postoperative Complications | 0 percentage of participants |