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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Endometrial Clear Cell Adenocarcinoma; Endometrial Serous Adenocarcinoma; Endometrial Mixed Adenocarcinoma; Grade 3 Endometrial Endometrioid Adenocarcinoma; Malignant Mixed Mesodermal (Mullerian) Tumor
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Procedure: Computed Tomography; Drug: Indocyanine Green Solution; Procedure: Lymph Node Mapping; Procedure: Lymphadenectomy; Procedure: Positron Emission Tomography

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center
    • Houston, Texas, United States, 77026-1967
      • Lyndon Baines Johnson General Hospital
    • Houston, Texas, United States, 77054
      • The Woman's Hospital of Texas
    • Houston, Texas, United States, 77094
      • MD Anderson Regional Care Center-Katy
    • Nassau Bay, Texas, United States, 77058
      • MD Anderson Regional Care Center-Bay Area
    • Sugar Land, Texas, United States, 77478
      • MD Anderson Regional Care Center-Sugar Land
    • The Woodlands, Texas, United States, 77384
      • MD Anderson Regional Care Center-The Woodlands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: Laboratory Biomarker Analysis; Correlative studies; Procedure: Computed Tomography; Undergo PET/CT; Other Names: CT; CAT; CAT Scan; Computerized Axial Tomography; tomography; computerized tomography; CT SCAN; Drug: Indocyanine Green Solution; Given via superficial and deep cervical injection; Other Names: IC-GREEN; ICG Solution; Procedure: Lymph Node Mapping; Undergo lymph node mapping; Other Names: lymphatic mapping; Procedure: Lymphadenectomy; Undergo full lymphadenectomy; Other Names: excision of the lymph node; Lymph Node Dissection; lymph node excision; Procedure: Positron Emission Tomography; Undergo PET/CT; Other Names: Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron Emission Tomography Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
Incidence of intra-operative complications	Morbidity and mortality data will be tabulated, including intra-operative complications.	At time of surgery
Incidence of post-operative complications	Morbidity and mortality data will be tabulated, including post-operative complications.	At time of surgery

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Pamela Soliman, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2013
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: November 27, 2012
• First Submitted That Met QC Criteria: November 27, 2012
• First Posted (Estimated): November 29, 2012

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Neoplastic Processes; Neoplasms, Complex and Mixed; Sarcoma; Neoplasm Metastasis; Cystadenocarcinoma; Neoplasms, Cystic, Mucinous, and Serous; Ovarian Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Adenocarcinoma; Endometrial Neoplasms; Mixed Tumor, Mullerian; Lymphatic Metastasis; Cystadenocarcinoma, Serous; Carcinoma, Endometrioid; Adenocarcinoma, Clear Cell; Mixed Tumor, Mesodermal; Pharmaceutical Solutions
• Other Study ID Numbers: 2012-0623 (Other Identifier: M D Anderson Cancer Center); P50CA098258 (U.S. NIH Grant/Contract); NCI-2015-01898 (Registry Identifier: CTRP (Clinical Trial Reporting Program))