This phase II trial studies how well image-guided brachytherapy in the Advanced Multimodality Image Guided Operating (AMIGO) suite works in treating patients with gynecological cancers that are stage I-IVA or have come back. Brachytherapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Imaging in the AMIGO suite may help in planning radiation therapy and may result in lower doses and less toxicity.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01399658.
PRIMARY OBJECTIVE:
I. To determine doses to the rectum, sigmoid and bladder obtained after AMIGO-guided placement compared to standard computed tomography (CT) guided treatment with the anticipation that AMIGO-guided placement will result in lower organs at risk (OAR) dosing than standard CT-based imaging.
SECONDARY OBJECTIVES:
I. To assess 90-day toxicity comparing AMIGO results to those obtained in prior CT and magnetic resonance therapy (MRT) units.
II. To evaluate the utility of techniques such as electromagnetic (EM) micro-coils, magnetic resonance (MR)-tracking stylets and oxygen breathing in improving the ability to position, track brachytherapy catheters, particularly in cases where more than ten interstitial catheters are used, and examine ways to use active tracking of high-dose-rate (HDR) needles to provide quantitative feedback about needle position and implant quality.
OUTLINE:
Patients undergo optional planning magnetic resonance imaging (MRI), MRI with optional MR sequence during oxygen breathing, MR diffusion-weighted imaging (DWI), and optional fluorine-18 (18F)-fluoromisonidazole (FMISO) positron emission tomography (PET) followed by magnetic resonance- or ultrasound (US)-guided brachytherapy in the AMIGO suite. Patients may also undergo an optional fludeoxyglucose F 18 (FDG)-PET/CT scan prior to brachytherapy.
After completion of study treatment, patients are followed up at 90 and 180 days.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorMartin T. King
