Image-Guided Gynecologic Brachytherapy (AMIGO)
|Cervical Cancer Uterine Cancer Vaginal Cancer Carcinoma of the Vulva||Procedure: Image-guided brachytherapy||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Clinical Trial to Evaluate Image-Guided Gynecologic Brachytherapy in the Advanced Multimodality Image-Guided Operating Suite (AMIGO)|
- Dose determination [ Time Frame: 3 years ]To determine doses to the rectum, sigmoid and bladder obtained after AMIGO-guided placement compared to standard CT-guided treatment with the anticipation that AMIGO-guided placement will result in lower OAR dosing than standard CT-based imaging.
- Toxicities: gastrointestinal, genitourinary, and skin [ Time Frame: 3 years ]
- To measure toxicities, including gastrointestinal, genitourinary, and skin, from physician-queries using the Common Toxicity Criteria for Adverse Events (CTCAE 4.0)
- To assess 90-day gastrointestinal, genitourinary, and skin toxicities and to compare AMIGO results to those obtained in prior CT and Magnetic Resonance Therapy (MRT) units.
|Study Start Date:||September 2011|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
Experimental: Image-Guided Brachytherapy
Procedure: Image-guided brachytherapy
MRI-guided application of brachytherapy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399658
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Paul Nguyen, MD||Brigham and Women's Hospital|