Endometrial Clear Cell AdenocarcinomaNCT01737619
PET/CT and Lymph Node Mapping in Finding Lymph Node Metastasis in Patients With High-Risk Endometrial Cancer
A study testing Computed Tomography, Indocyanine Green Solution and Laboratory Biomarker Analysis in people with Endometrial Clear Cell Adenocarcinoma and Endometrial Mixed Adenocarcinoma, run by M.D. Anderson Cancer Center at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Clear Cell Adenocarcinoma, Endometrial Mixed Adenocarcinoma, Endometrial Serous Adenocarcinoma
- What is being tested?
- Computed Tomography, Indocyanine Green Solution and Laboratory Biomarker Analysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 7 sitesUnited States
- Study dates
- 3 Apr 2013to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026-1967
M D Anderson Cancer Center
Houston, Texas, 77030
The Woman's Hospital of Texas
Houston, Texas, 77054
MD Anderson Regional Care Center-Katy
Houston, Texas, 77094
MD Anderson Regional Care Center-Bay Area
Nassau Bay, Texas, 77058
MD Anderson Regional Care Center-Sugar Land
Sugar Land, Texas, 77478
MD Anderson Regional Care Center-The Woodlands
The Woodlands, Texas, 77384
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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
- Endometrial Clear Cell Adenocarcinoma, Endometrial Mixed Adenocarcinoma, Endometrial Serous Adenocarcinoma, Grade 3 Endometrial Endometrioid Adenocarcinoma, Malignant Mixed Mesodermal (Mullerian) Tumor
- Being tested
- Computed Tomography, Indocyanine Green Solution, Laboratory Biomarker Analysis, Lymph Node Mapping, Lymphadenectomy
- Medical subject headings
- Mixed Tumor, Mesodermal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, computerized tomography
Undergo PET/CT
Indocyanine Green SolutionDrug
Also called IC-GREEN, ICG Solution
Given via superficial and deep cervical injection
Laboratory Biomarker AnalysisOther
Correlative studies
Lymph Node MappingProcedure or surgery
Also called lymphatic mapping
Undergo lymph node mapping
LymphadenectomyProcedure or surgery
Also called excision of the lymph node, Lymph Node Dissection, lymph node excision
Undergo full lymphadenectomy
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (PET/CT, lymph node mapping) | Experimental | 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. Receives: Procedure: Computed Tomography; Drug: Indocyanine Green Solution; Other: Laboratory Biomarker Analysis; Procedure: Lymph Node Mapping; Procedure: Lymphadenectomy; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (2)
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
Measured: 36 months
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study start3 Apr 2013
- Primary completion30 Apr 2025
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endometrial Clear Cell AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Pamela Soliman, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737619
- Sponsor's protocol ID
- 2012-0623
- Other IDs
- NCI-2015-01898, 2012-0623, P50CA098258
- Status last verified
- Oct 2026
- First submitted
- 27 Nov 2012
- Last updated
- 8 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov