Analysis of Parametrial Lymph Nodes as Sentinel Nodes in Patients With Cervical Cancer

NCT00631241 | Completed

• 1 other identifier: 2006-0153
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to find out if the parametrial nodes are "sentinel" nodes (the lymph nodes believed to be the greatest risk for the spread of cancer) and if intraoperative lymphatic mapping can identify "sentinel" lymph nodes in the parametrium (the tissue that is on either side of the cervix). Identifying these lymph nodes may help to predict the status of the remaining lymph nodes in the pelvis. This research will also determine if India Ink is safe to use with the blue dye and radioactive tracer and if it improves the process of identifying the sentinel nodes.

Conditions

Cervical Cancer

Keywords

Cervical Cancer; Parametrial Lymph Nodes; Sentinel Nodes; Intraoperative Lymphatic Mapping; Single Photon Emission Computed Tomography; SPECT/CT

Outcome Measures

Primary Outcomes (1)

• Number of Patients with sentinel lymph nodes in the parametrium

  Sentinel nodes classified according to modification of American Joint Committee on Cancer (AJCC) staging for axillary nodes from breast cancer as follows: 1) metastases present - tumor \> 2.0 mm in diameter; 2) micrometastases present - tumor cell aggregates between 0.2 and 2.0 mm in diameter; 3) isolated tumor cells - individual tumor cells or aggregates \<0.2 mm in diameter, usually detected by immunohistochemistry; or 4) tumor absent - no tumor cells identified in H\&E (or immunohistochemically) stained sections. Parametrium separated from cervix/uterus by pathology then away from primary cervical lesion will be re-examined for sentinel nodes both visually \& with handheld gamma counter; \& all parametrial tissue will be submitted for pathologic sectioning to detect carbon particles in parametrial sentinel nodes not detected by gamma counter or direct visualization.

  Determination during surgery (with intraoperative lymphatic mapping)

Study Arms (1)

Intraoperative Lymphatic Mapping

EXPERIMENTAL

Single Photon Emission Computed Tomography - First 3 Patients = Performed 30-45 minutes, 2-3 hours, and 20-24 hours after injections of the radioactive material or just before surgery; Remaining 17 Patients = Performed only one at a time as was found to be best based on the scans from first 3 patients. Isosulfan Blue and India ink will be injected into the cervix to help the surgeon identify the sentinel nodes by their blue color and their level of radioactivity.

Procedure: Single Photon Emission Computed Tomography; Procedure: Intraoperative Lymphatic Mapping

Interventions

Single Photon Emission Computed Tomography PROCEDURE

First 3 Patients = Performed 30-45 minutes, 2-3 hours, and 20-24 hours after injections of the radioactive material or just before surgery; Remaining 17 Patients = Performed only one at a time as was found to be best based on the scans from first 3 patients.

Also known as: SPECT/CT

Intraoperative Lymphatic Mapping

Intraoperative Lymphatic Mapping PROCEDURE

Isosulfan Blue and India ink will be injected into the cervix to help the surgeon identify the sentinel nodes by their blue color and their level of radioactivity.

Intraoperative Lymphatic Mapping

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are dispositioned to undergo radical hysterectomy or radical trachelectomy and pelvic lymphadenectomy.
• No evidence of metastases on computed tomography, magnetic resonance imaging, or PET/CT scan.
• Patients must be good surgical candidates.
• Patients who have signed an approved informed consent and authorization permitting release of personal health information.
• For patients of child-bearing age, a negative serum pregnancy test within 72 hours prior to injection of radiocolloid. Child-bearing potential is defined as not post-menopausal for 12 months or no previous surgical sterilization.

You may not qualify if:

• Patients with known allergies to triphenylmethane compounds or India ink.
• Patients with a history of retroperitoneal surgery.
• Patients with a history of pelvic irradiation.
• Patients who had a cold knife or LEEP cone biopsy within 4 weeks of enrollment.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Michael M. Frumovitz, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: March 7, 2008
• Study Start: February 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: May 2, 2016

Record last verified: 2016-04

Locations

US (1)