Know Cancer

or
forgot password

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


N/A
18 Years
N/A
Open (Enrolling)
Female
Gynecologic Cancer

Thank you

Trial Information

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


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.


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 on
preoperative imaging

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
3. Does not meet histologic criteria

4. Evidence of peritoneal or distant metastasis on preoperative imaging

5. Baseline creatinine (necessary for imaging studies)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Comparison of PET/CT Versus Sentinel Lymph Node Mapping in Detecting Endometrial Cancer Lymph Nodes

Outcome Description:

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.

Outcome Time Frame:

1 day

Safety Issue:

No

Principal Investigator

Pamela Soliman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2012-0623

NCT ID:

NCT01737619

Start Date:

April 2013

Completion Date:

Related Keywords:

  • Gynecologic Cancer
  • 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
  • Endometrial Neoplasms
  • Neoplasm Metastasis
  • Adenoma

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030