Lymphoscintigraphy in Patients With Vaginal Cancer

NCT00528034 | Completed

• 1 other identifier: ID02-239
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

1. 1.Determine the feasibility of using pretreatment lymphoscintigraphy to identify the sentinel lymph node(s) in patients with vaginal cancer dispositioned to receive radiation therapy.
2. 2.Determine the feasibility of using preoperative lymphoscintigraphy and intraoperative lymphatic mapping to identify the sentinel lymph node(s) in patients with vaginal cancer dispositioned to undergo surgery and bilateral lymph node dissection.

Conditions

Vaginal Cancer

Keywords

Vaginal Cancer; Lymphoscintigraphy; Lymphatic Mapping; Sentinel Lymph Node; Isosulfan Blue; Lymph

Outcome Measures

Primary Outcomes (1)

• Identification of sentinel lymph node(s) in patients with vaginal cancer using lymphoscintigraphy and intraoperative lymphatic mapping.

  Preoperative and intraoperative, prior to radiation therapy, data collection

Study Arms (1)

Lymphoscintigraphy

EXPERIMENTAL

Procedure: Lymphoscintigraphy

Interventions

Lymphoscintigraphy PROCEDURE

Procedure where a very small amount (less than one tenth of a teaspoon) of a radioactive material is injected around the edge of the tumor in the vagina, followed immediately by the scan. The scan is done before the patient has surgery or begins radiation therapy.

Lymphoscintigraphy

Eligibility Criteria

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

You may qualify if:

• Patients must have invasive vaginal cancer, any histology, any stage.
• Patients with prior excision of the primary are eligible.
• Patients with recurrent vaginal cancer who have not had a prior inguinal or groin lymph node dissection.
• Patients undergoing either surgical resection and assessment of inguinal or groin lymph nodes, radiation therapy and/or chemotherapy.
• Patients must sign an IRB approved informed consent.

You may not qualify if:

• Known allergy to triphenylmethane compounds.
• Pregnancy.
• Prior radiation therapy to the vagina, vulva, groin or pelvis.
• Prior inguinal, femoral or pelvic lymphadenectomy.
• Patients who are not good surgical candidates.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Frumovitz M, Gayed IW, Jhingran A, Euscher ED, Coleman RL, Ramirez PT, Levenback CF. Lymphatic mapping and sentinel lymph node detection in women with vaginal cancer. Gynecol Oncol. 2008 Mar;108(3):478-81. doi: 10.1016/j.ygyno.2007.12.001. Epub 2008 Jan 10.

  PMID: 18190952 RESULT

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Vaginal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Charles Levenback, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 10, 2007
• First Posted: September 11, 2007
• Study Start: September 1, 2002
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: August 1, 2012

Record last verified: 2012-07

Locations

US (1)