MDACC Study Summary 2007-0206 (Archived)

Study Summary
No. 2007-0206:.......Endometrial......Michael M. Frumovitz......Gynecologic Oncology

Study Summary Title



Study Summary Number:	2007-0206

Study Title:	Hysteroscopic Injection of Tracers for Sentinel Node Identification in Women with Endometrial Cancer

Physician

New Patient Referral



Name:	Michael M. Frumovitz	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Gynecologic Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-9599 Contact us about clinical trials

General Information



Disease Group:	Endometrial	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	n/a

Treatment Agents:	Technetium 99M Tc-Hynic-rh-Annexin V	Home Care:	n/a

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this clinical research study is to learn if a procedure called intraoperative (during surgery) lymphatic mapping can be used to find the sentinel lymph node in patients with endometrial cancer.

Study Objectives / Outcomes

Primary: To examine the feasibility and sentinel node identification rate of intraoperative hysteroscopic injection of patent blue dye and radiocolloid for the detection of sentinel lymph nodes in patients with endometrial cancer.

Secondary:
1. To map the location(s) of sentinel node(s) draining primary endometrial cancer lesions.
2. To determine negative predictive value and false-negative rate for intraoperative hysteroscopic injection of patent blue dye and radiocolloid for the detection of sentinel lymph nodes in patients with endometrial cancer.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	07/18/2007

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	20

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients with biopsy confirmed endometrial cancer who have been dispositioned to undergo total hysterectomy, bilateral salpingooophorectomy and lymph node staging.

2) Surgical procedures may be performed by either laparotomy or laparoscopy.

3) If computed tomography, magnetic resonance imaging, lymphangiography, or ultrasound has been performed for preoperative assessment, there must be no evidence of metastases. Imaging is not mandatory.

4) Patients who have signed an approved informed consent and authorization permitting release of personal health information.

Exclusion Criteria:

1) Patients with a preoperative diagnosis of grade I endometrioid adenocarcinoma of the uterus.

2) Patients with uterine papillary serous carcinoma.

3) Patients who have undergone endometrial ablation or a myomectomy within 1 year of the surgery for endometrial cancer.

4) Patients with known allergies to triphenylmethane compounds or techniciun-99 radiocolloid.

5) Patients with a history of retroperitoneal surgery.

6) Patients with a history of pelvic radiation.

7) Patients with no lesion visible on hysteroscopy.

8) Patients with previous exposure to the tracer (to prevent risk of allergic reaction).

Links

Registration Number: NCT00671606
Study Information on Clinical Trials Registry (clinicaltrials.gov)