High Risk Endometrial Cancer and Lymph Nodes Metastasis
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.
Procedure: PET/CT Scan
Procedure: Sentinel Lymph Node Mapping
|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|
- 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.
|Study Start Date:||April 2013|
|Estimated Primary Completion Date:||April 2019 (Final data collection date for primary outcome measure)|
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:Procedure: Sentinel Lymph Node Mapping
Blue dye, a radioactive colloid, and/or an indocyanine green (IC-Green) dye injected into cervix during surgery.
If you are found eligible to take part in this study, you will have a PET/CT scan before your surgery and an endometrial biopsy 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.
Any blood left over from screening or lymph node tissue leftover from the study will be stored in the gynecologic research bank at MD Anderson for future research related to cancer.
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.
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. All will be enrolled at MD Anderson.
|Contact: Pamela Soliman, MD||713-745-2352|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Pamela Soliman, MD||UT MD Anderson Cancer Center|