Image-Guided Gynecologic Brachytherapy
Conditions
Cervical Cancer - Uterine Cancer - Vaginal Cancer - Carcinoma of the Vulva
Conditions: official terms
Uterine Cervical Neoplasms - Uterine Neoplasms - Vaginal Neoplasms - Vulvar Neoplasms
Conditions: Keywords
Brachytherapy, Gynecological cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Image-guided brachytherapy
Type: Procedure
Overall Status
Recruiting
Summary
Standard therapy for gynecologic cancers involves the use of brachytherapy, also called internal radiation therapy or implant radiation. The treatment being studied consists of standard brachytherapy with the additional use of MRI to guide the insertion of radioactive applicators. The purpose of the study is to find out whether MRI-guided brachytherapy is practical and beneficial when compared to the standard CT-guided brachytherapy placement. The investigators are hoping that this MRI procedure will decrease the risk of giving too high a radiation dose to the bladder or bowel.
Detailed Description
The insertion of the brachytherapy applicator will be administered in the Advanced Multimodality Image-Guided Operating (AMIGO) suite at Brigham and Women's Hospital. Subjects will undergo an MRI scan in the AMIGO suite ensuring proper placement of the applicator. Subjects may have an optional FLT-PET scan.

Subjects will have a follow-up visit including physical exam, pap smear, and MRI of the pelvis and/or PET scan 90 days after treatment.

Subjects will have a follow-up visit including physical exam, pap smear, and MRI of the pelvis and/or PET scan 180 days after treatment.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Histologically or cytologically confirmed carcinoma of the cervix (Stage I-IVA), carcinoma of the uterus (Stage IIIB), carcinoma of the vagina (Stage I-IVA), or carcinoma of the vulva (stage I-IVA)

- Life expectancy > 6 months

- MRI of the pelvis and/or PET-CT within 4 months prior to entering study

Exclusion Criteria:

- Uncontrolled intercurrent illness

- Pacemaker, brain aneurysm clip, inner ear implant, neurostimulator, or metal fragments in the eye
Location
Brigham and Women's Hospital
Boston, Massachusetts, United States
Status: Recruiting
Contact: Akila N Viswanathan, MD MPH - 617-732-6331
Start Date
September 2011
Sponsors
Dana-Farber Cancer Institute
Source
Dana-Farber Cancer Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page