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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01737619
First Posted: November 29, 2012
Last Update Posted: November 15, 2016
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
The goal of this clinical research study is to compare positron emission tomography/computed tomography (PET/CT) scans and sentinel lymph node mapping in finding lymph nodes that have endometrial cancer.

Condition Intervention
Gynecologic Cancer Procedure: PET/CT Scan Procedure: Sentinel Lymph Node Mapping

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Comparison of PET/CT Versus Sentinel Lymph Node Mapping in Detecting Endometrial Cancer Lymph Nodes [ Time Frame: 1 day ]
    Estimation of false negative rate for each procedure (PET/CT, sentinel lymph node mapping) and for the combination of the 2 procedures with 90% credible intervals. Posterior probability that the false negative rate is > 10% for each procedure and for the combination of the 2 procedures reported. Biopsy and frozen section analysis tabulated with final histologic grade and surgical stage, and chi-square test used to assess associations between biopsy and frozen section with grade and stage.


Estimated Enrollment: 150
Study Start Date: April 2013
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sentinel Lymph Node Mapping

PET/CT prior to surgery. Surgical approach as determined by the primary surgeon.

At time of surgery, an endometrial biopsy will be performed once the patient is under anesthesia. Intra-operative lymphatic mapping with blue dye, radioactive colloid, and/or indocyanine green will be performed. Sentinel lymph nodes will be removed and labeled as blue, green, and/or hot. These nodes will be processed separately.

Procedure: PET/CT Scan
PET/CT scan before surgery and sentinel lymph node mapping procedure.
Other Names:
  • Positron Emission Tomography Scan
  • Computed Tomography Scan
Procedure: Sentinel Lymph Node Mapping
Blue dye, a radioactive colloid, and/or an indocyanine green (IC-Green) dye injected into cervix during surgery.

Detailed Description:

If you are found eligible to take part in this study, you will have a PET/CT scan before your surgery and sentinel lymph node mapping procedure during the surgery.

For the sentinel lymph node mapping procedure, a blue dye, a radioactive colloid, and/or an indocyanine green (IC-Green) dye will be injected into your cervix during your surgery. The study staff will then use a device that detects radioactivity and that looks for lymph nodes stained with the dye(s). When the study staff locates the sentinel lymph nodes, they will remove them. The sentinel lymph nodes will then be sent to a lab where a pathologist will check them to see if they contain cancer cells. Other lymph nodes may be removed as part of your standard of care surgery if your surgeon thinks it is in your best interest.

Length of Study:

Your participation in this study will be over after your surgery.

This is an investigational study. The 2 procedures being compared in this study are standard of care.

Up to 150 participants will be enrolled in this study. Up to 10 will be enrolled at the Harris Health System.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Histologically confirmed high grade endometrial cancer including grade 3 endometrioid, serous, clear cell, MMMT or any mixed tumor containing one of these cell types
  2. Patients with a grade 1/2 tumors and evidence of deep myometrial invasion or cervical involvement on preoperative imaging or physical exam
  3. Candidate for surgery.
  4. No evidence of peritoneal disease on preoperative imaging
  5. Negative pregnancy test if of child-bearing age
  6. No preoperative treatment for endometrial cancer including radiation or chemotherapy
  7. Previous hormonal therapy is allowed

Exclusion Criteria:

  1. Medical co-morbidities making surgery unsafe, as determined by the primary treating physician
  2. Any contraindications to PET/CT or lymph node mapping (inability to control serum glucose to a value of </= 200 mg/dl for FDG-PET/CT)
  3. Does not meet histologic criteria
  4. Evidence of peritoneal or distant metastasis on preoperative imaging
  5. Baseline creatinine (necessary for imaging studies)
  Contacts and Locations
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
United States, Texas
Lyndon B. Johnson General Hospital
Houston, Texas, United States, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Pamela Soliman, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01737619     History of Changes
Other Study ID Numbers: 2012-0623
5 P50 CA098258-08 COEUS 4892 ( Other Identifier: SPORE )
NCI-2015-01898 ( Registry Identifier: NCI CTRP )
First Submitted: November 27, 2012
First Posted: November 29, 2012
Last Update Posted: November 15, 2016
Last Verified: November 2016

Keywords provided by M.D. Anderson Cancer Center:
Gynecologic cancer
Endometrial Cancer
Lymph Nodes Metastasis
Surgical Staging
False negative rate
Detection of positive lymph nodes
Histologically confirmed high grade endometrial cancer
Sentinel lymph node mapping

Additional relevant MeSH terms:
Neoplasm Metastasis
Endometrial Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female