Prospective Evaluation of Lymph Node Metastasis at the Time of Surgical Staging for 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 : April 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gynecologic Cancer||Procedure: PET/CT Scan Procedure: Sentinel Lymph Node Mapping||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Evaluation of Lymph Node Metastasis at the Time of Surgical Staging for High Risk Endometrial Cancer|
|Actual Study Start Date :||April 2013|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2021|
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.
- 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.
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
|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|
|Principal Investigator:||Pamela Soliman, MD||M.D. Anderson Cancer Center|