Vaginal Cancer Clinical Trial
Official title:
Lymphoscintigraphy and Selective Lymphatic Mapping in Patients With Invasive Vaginal Cancer
Verified date | July 2012 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Primary Objectives:
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. 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.
Status | Completed |
Enrollment | 14 |
Est. completion date | May 2008 |
Est. primary completion date | May 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | U.T.M.D. Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
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 1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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