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

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Cervical Cancer, Endometrial Cancer, Cervical Carcinoma

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Trial Information

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

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

Inclusion Criteria:

- Patients with endometrial cancer diagnosed on endometrial biopsy or dilatation and

- 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

- 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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To determine the feasibility of identifying the sentinel lymph node in patients with endometrial and invasive cervical cancer using a combination of radioisotope and blue dye.

Outcome Time Frame:

7 years

Safety Issue:


Principal Investigator

Mary Gemignani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 2003

Completion Date:

September 2011

Related Keywords:

  • Cervical Cancer
  • Endometrial Cancer
  • Cervical Carcinoma
  • Cervix
  • Endometrium
  • Cervical Carcinoma
  • Lymphatic Mapping
  • Carcinoma
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Adenoma



Memorial Sloan Kettering Cancer Center New York, New York  10021