High Risk Endometrial Cancer and Lymph Nodes Metastasis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01737619
First received: November 27, 2012
Last updated: August 12, 2014
Last verified: August 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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: 100
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:

The blood drawn at screening and any leftover lymph node tissue from screening will be stored in the gynecologic research bank at MD Anderson for future research related to cancer and biomarker testing.

Before your samples can be used for research, the researchers must get approval from the Institutional Review Board (IRB) of MD Anderson. The IRB is a committee of doctors, researchers, and community members. The IRB is responsible for protecting study participants and making sure all research is safe and ethical.

Your samples will be given a code number. No identifying information will be directly linked to your samples. Only the researcher in charge of the bank will have access to the code numbers and be able to link the samples to you. This is to allow medical data related to the samples to be updated as needed.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737619

Contacts
Contact: Pamela Soliman, MD 713-745-2352

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Lyndon B. Johnson General Hospital Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Pamela Soliman, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

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
Study First Received: November 27, 2012
Last Updated: August 12, 2014
Health Authority: United States: Institutional Review Board

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
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014