Intra-Operative Lymphatic Mapping in Patients With Invasive Carcinoma of the Cervix or Endometrial Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2011-09-30

Brief Summary

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The purpose of this study is to learn if a surgical technique called intraoperative lymphatic mapping can accurately identify the lymph node that is at greatest risk if endometrial or cervical cancer spreads to the lymph nodes.

Early cervical cancer is usually treated by removing the cervix, tissue around the cervix, and the upper vagina. If needed, the uterus is also removed. The treatment also includes removing lymph nodes from the pelvis. Endometrial cancer is usually treated by removing the cervix, uterus, fallopian tubes and ovaries.

The treatment also includes removing lymph nodes from the pelvis.

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Detailed Description

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Patients with FIGO stage I endometrial cancer or patients with FIGO stage I-IIA invasive cervical cancer and who will be undergoing surgical management to include a lymphadenectomy.

↓ Injection of radioisotope and preoperative lymphoscintigraphy with Tc99m either the day before or on the day of surgery by the Nuclear Medicine Department.

↓ Intraoperative lymphatic mapping with blue dye and gamma probe.

↓ Hysterectomy, Radical hysterectomy and/or radical trachelectomy and pelvic lymphadenectomy.

Conditions

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Cervical Cancer Endometrial Cancer Cervical Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Lymphatic Mapping

Intervention Type OTHER

Intra-Operative Lymphatic Mapping

Interventions

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Lymphatic Mapping

Intra-Operative Lymphatic Mapping

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with endometrial cancer diagnosed on endometrial biopsy or dilatation and curettage.
* Patients with invasive cervical cancer diagnosed on cervical biopsy or cone biopsy.
* Patients with a performance status of 0, 1, 2, or 3 by the Gynecologic Oncology Group criteria (Appendix).
* Patients with stage I to \~IIA invasive cervical cancer disease according to the International Federation of Gynecology and Obstetrics (FIGO) clinical staging criteria (Appendix).
* Patients with clinical stage I endometrial cancer
* Patients who will undergo surgery to include a hysterectomy, radical hysterectomy and/or radical trachelectomy and bilateral lymphadenectomy via laparotomy or laparoscopy
* Patients who have signed an approved informed consent.

Exclusion Criteria

* Patients with history of prior pelvic or para-aortic lymphadenectomy.
* Patients with stage IIB-IV invasive cervical cancer by FIGO criteria.
* Patients with recurrent endometrial or cervical cancer.
* Patients with prior pelvic radiation.
* Any patient with endometrial or cervical cancer treated with neoadjuvant chemotherapy and radiation therapy.
* Patients with a performance score of 4 by the Gynecologic Oncology Group criteria or who are not good surgical candidates (Appendix).
* Patients with grossly infected primary tumors.
* Patients with known allergy to triphenyl-ethane compounds.
* Patients with known deficiency of Glucose-G-Phosphate Dehydrogenase.
* Patients with known Hemolytic Anemia from Pyruvate Kinase and G6PD Deficiencies.
* Severe Renal Disease.

Eligible Sex

ALL

Accepts Healthy Volunteers

No