Image-Guided Gynecologic Brachytherapy

Study Overview
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Brief Summary
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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
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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 FMISO-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.

Official Title
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A Clinical Trial to Evaluate Image-Guided Gynecologic Brachytherapy in the Advanced Multimodality Image-Guided Operating Suite (AMIGO)

Conditions
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Cervical Cancer, Uterine Cancer, Vaginal Cancer, Carcinoma of the Vulva

Intervention / Treatment
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* Procedure: Image-guided brachytherapy
* Drug: 3'-Deoxy-3'-18f-Fluorothymidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Image-Guided Brachytherapy<br>Image-guided brachytherapy | Procedure: Image-guided brachytherapy<br>* MRI-guided application of brachytherapy<br>* Other names: implant radiation;Drug: 3'-Deoxy-3'-18f-Fluorothymidine<br>* Assessing tumor proliferation in Gynecologic cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Doses Given | Doses given to the tumor, rectum, and sigmoid obtained after AMIGO-guided placement. | Measured while on treatment, up to 2 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brachytherapy, Gynecological cancer