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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01737619
Recruitment Status : Active, not recruiting
First Posted : November 29, 2012
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Endometrial Clear Cell Adenocarcinoma Endometrial Mixed Adenocarcinoma Endometrial Serous Adenocarcinoma Grade 3 Endometrial Endometrioid Adenocarcinoma Malignant Mixed Mesodermal (Mullerian) Tumor Procedure: Computed Tomography Drug: Indocyanine Green Solution Other: Laboratory Biomarker Analysis Procedure: Lymph Node Mapping Procedure: Lymphadenectomy Procedure: Positron Emission Tomography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Evaluation of Lymph Node Metastasis at the Time of Surgical Staging for High Risk Endometrial Cancer
Actual Study Start Date : April 3, 2013
Estimated Primary Completion Date : April 30, 2025
Estimated Study Completion Date : April 30, 2025


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.
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • computerized tomography
  • CT
  • CT SCAN
  • tomography

Drug: Indocyanine Green Solution
Given via superficial and deep cervical injection
Other Names:
  • IC-GREEN
  • ICG Solution

Other: Laboratory Biomarker Analysis
Correlative studies

Procedure: Lymph Node Mapping
Undergo lymph node mapping
Other Name: 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




Primary Outcome Measures :
  1. False negative rate of positron emission tomography (PET)/computed tomography (CT) [ Time Frame: Baseline ]
    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.

  2. False negative rate of sentinel lymph node mapping [ Time Frame: At time of surgery ]
    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.


Secondary Outcome Measures :
  1. Concordance for each procedure and for the combination of both procedures [ Time Frame: At time of surgery ]
    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.

  2. Sensitivity of each procedure and for the combination of both procedures [ Time Frame: At time of surgery ]
    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.

  3. Specificity of each procedure and for the combination of both procedures [ Time Frame: At time of surgery ]
    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.

  4. Positive predictive value (PPV) of each procedure and for the combination of both procedures [ Time Frame: At time of surgery ]
    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.

  5. Negative predictive value (NPV) of each procedure and for the combination of both procedures [ Time Frame: At time of surgery ]
    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.

  6. CA-125 levels [ Time Frame: Baseline ]
    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.

  7. HE4 levels [ Time Frame: Baseline ]
    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.

  8. Metabolic parameters [ Time Frame: Baseline ]
    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.

  9. Incidence of intra-operative complications [ Time Frame: At time of surgery ]
    Morbidity and mortality data will be tabulated, including intra-operative complications.

  10. Incidence of post-operative complications [ Time Frame: At time of surgery ]
    Morbidity and mortality data will be tabulated, including post-operative complications.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737619


Locations
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United States, Texas
Lyndon Baines Johnson General Hospital
Houston, Texas, United States, 77026-1967
M D Anderson Cancer Center
Houston, Texas, United States, 77030
The Woman's Hospital of Texas
Houston, Texas, United States, 77054
MD Anderson Regional Care Center-Katy
Houston, Texas, United States, 77094
MD Anderson Regional Care Center-Bay Area
Nassau Bay, Texas, United States, 77058
MD Anderson Regional Care Center-Sugar Land
Sugar Land, Texas, United States, 77478
MD Anderson Regional Care Center-The Woodlands
The Woodlands, Texas, United States, 77384
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Pamela Soliman M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01737619    
Other Study ID Numbers: 2012-0623
NCI-2015-01898 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2012-0623 ( Other Identifier: M D Anderson Cancer Center )
P50CA098258 ( U.S. NIH Grant/Contract )
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Adenocarcinoma
Endometrial Neoplasms
Cystadenocarcinoma, Serous
Carcinoma, Endometrioid
Adenocarcinoma, Clear Cell
Mixed Tumor, Mullerian
Mixed Tumor, Mesodermal
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous
Ovarian Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Neoplasms, Complex and Mixed
Sarcoma
Neoplasms, Connective and Soft Tissue
Pharmaceutical Solutions