Image-Guided Gynecologic Brachytherapy (AMIGO)
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|ClinicalTrials.gov Identifier: NCT01399658|
Recruitment Status : Active, not recruiting
First Posted : July 22, 2011
Last Update Posted : March 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Uterine Cancer Vaginal Cancer Carcinoma of the Vulva||Procedure: Image-guided brachytherapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Trial to Evaluate Image-Guided Gynecologic Brachytherapy in the Advanced Multimodality Image-Guided Operating Suite (AMIGO)|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||June 2021|
Experimental: Image-Guided Brachytherapy
Procedure: Image-guided brachytherapy
MRI-guided application of brachytherapy
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01399658
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Larissa Lee, MD||Brigham and Women's Hospital|