A Clinical Trial to Evaluate Image-Guided Gynecologic Brachytherapy in the Advanced Multimodality Image-Guided Operating Suite (AMIGO)
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose determination
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.
3 years
No
Akila N Viswanathan, M.D., M.P.H.
Principal Investigator
Brigham and Women's Hospital
United States: Institutional Review Board
11-098
NCT01399658
September 2011
Name | Location |
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Brigham and Women's Hospital | Boston, Massachusetts 02115 |