PET/CT and Lymph Node Mapping in Finding Lymph Node Metastasis in Patients With High-Risk Endometrial Cancer
NCT ID: NCT01737619
Last Updated: 2025-11-28
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
101 participants
INTERVENTIONAL
2013-04-03
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (PET/CT, lymph node mapping)
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.
Computed Tomography
Undergo PET/CT
Indocyanine Green Solution
Given via superficial and deep cervical injection
Laboratory Biomarker Analysis
Correlative studies
Lymph Node Mapping
Undergo lymph node mapping
Lymphadenectomy
Undergo full lymphadenectomy
Positron Emission Tomography
Undergo PET/CT
Interventions
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Computed Tomography
Undergo PET/CT
Indocyanine Green Solution
Given via superficial and deep cervical injection
Laboratory Biomarker Analysis
Correlative studies
Lymph Node Mapping
Undergo lymph node mapping
Lymphadenectomy
Undergo full lymphadenectomy
Positron Emission Tomography
Undergo PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Pamela Soliman
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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Lyndon Baines Johnson General Hospital
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
The Woman's Hospital of Texas
Houston, Texas, United States
MD Anderson Regional Care Center-Katy
Houston, Texas, United States
MD Anderson Regional Care Center-Bay Area
Nassau Bay, Texas, United States
MD Anderson Regional Care Center-Sugar Land
Sugar Land, Texas, United States
MD Anderson Regional Care Center-The Woodlands
The Woodlands, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2015-01898
Identifier Type: REGISTRY
Identifier Source: secondary_id
2012-0623
Identifier Type: OTHER
Identifier Source: secondary_id
2012-0623
Identifier Type: -
Identifier Source: org_study_id
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