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

Endometrial Serous Adenocarcinoma Clinical Trial

Official title:

Prospective Evaluation of Lymph Node Metastasis at the Time of Surgical Staging for High Risk Endometrial Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01737619
• Other study ID #: 2012-0623
• Secondary ID: NCI-2015-0189820
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 3, 2013
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Endometrioid
• Endometrial Clear Cell Adenocarcinoma
• Endometrial Mixed Adenocarcinoma
• Endometrial Neoplasms
• Endometrial Serous Adenocarcinoma
• Grade 3 Endometrial Endometrioid Adenocarcinoma
• Lymphatic Metastasis
• Malignant Mixed Mesodermal (Mullerian) Tumor
• Mixed Tumor, Mesodermal
• Mixed Tumor, Mullerian

Intervention

Procedure:
• Computed Tomography
Undergo PET/CT

Drug:
• Indocyanine Green Solution
Given via superficial and deep cervical injection

Other:
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• Lymph Node Mapping
Undergo lymph node mapping
• Lymphadenectomy
Undergo full lymphadenectomy
• Positron Emission Tomography
Undergo PET/CT

Locations

Country	Name	City	State
United States	Lyndon Baines Johnson General Hospital	Houston	Texas
United States	M D Anderson Cancer Center	Houston	Texas
United States	MD Anderson Regional Care Center-Katy	Houston	Texas
United States	The Woman's Hospital of Texas	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

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	False negative rate of positron emission tomography (PET)/computed tomography (CT)	Compared with pathological findings as the gold standard. The false negative rate for the procedure and for the combination of the 2 procedures will be estimated with 90% credible intervals. The posterior probability that the false negative rate is > 10% for each procedure and for the combination of the 2 procedures will also be reported.	Baseline
Primary	False negative rate of sentinel lymph node mapping	Compared with pathological findings as the gold standard. The false negative rate for the procedure and for the combination of the 2 procedures will be estimated with 90% credible intervals. The posterior probability that the false negative rate is > 10% for each procedure and for the combination of the 2 procedures will also be reported.	At time of surgery
Secondary	Concordance for each procedure and for the combination of both procedures	The concordance for each procedure and for the combination of the 2 procedures will be estimated with 95% confidence intervals using pathologic findings as the gold standard.	At time of surgery
Secondary	Sensitivity of each procedure and for the combination of both procedures	The sensitivity of each procedure and for the combination of the 2 procedures will be estimated with 95% confidence intervals using pathologic findings as the gold standard.	At time of surgery
Secondary	Specificity of each procedure and for the combination of both procedures	The specificity of each procedure and for the combination of the 2 procedures will be estimated with 95% confidence intervals using pathologic findings as the gold standard.	At time of surgery
Secondary	Positive predictive value (PPV) of each procedure and for the combination of both procedures	The PPV of each procedure and for the combination of the 2 procedures will be estimated with 95% confidence intervals using pathologic findings as the gold standard.	At time of surgery
Secondary	Negative predictive value (NPV) of each procedure and for the combination of both procedures	The NPV of each procedure and for the combination of the 2 procedures will be estimated with 95% confidence intervals using pathologic findings as the gold standard.	At time of surgery
Secondary	CA-125 levels	Logistic regression methods will be used to model the logit of the probability of metastatic disease at the time of surgical staging as a function of CA-125 level, HE4 level, and other metabolic parameters including tumor intensity, metabolic tumor volume, and total lesion glycolysis. The odds ratio of the association between these factors and metastatic disease will be estimated with a 95% confidence interval. The logit of the probability of locoregional spread as a function of these factors will be similarly modeled. The correlations among these factors will also be estimated.	Baseline
Secondary	HE4 levels	Logistic regression methods will be used to model the logit of the probability of metastatic disease at the time of surgical staging as a function of CA-125 level, HE4 level, and other metabolic parameters including tumor intensity, metabolic tumor volume, and total lesion glycolysis. The odds ratio of the association between these factors and metastatic disease will be estimated with a 95% confidence interval. The logit of the probability of locoregional spread as a function of these factors will be similarly modeled. The correlations among these factors will also be estimated.	Baseline
Secondary	Metabolic parameters	Logistic regression methods will be used to model the logit of the probability of metastatic disease at the time of surgical staging as a function of CA-125 level, HE4 level, and other metabolic parameters including tumor intensity, metabolic tumor volume, and total lesion glycolysis. The odds ratio of the association between these factors and metastatic disease will be estimated with a 95% confidence interval. The logit of the probability of locoregional spread as a function of these factors will be similarly modeled. The correlations among these factors will also be estimated.	Baseline
Secondary	Incidence of intra-operative complications	Morbidity and mortality data will be tabulated, including intra-operative complications.	At time of surgery
Secondary	Incidence of post-operative complications	Morbidity and mortality data will be tabulated, including post-operative complications.	At time of surgery

External Links

•   MD Anderson Cancer Center Website