NCT01399658

Image-Guided Gynecologic Brachytherapy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Cervical Cancer
• Uterine Cancer
• Vaginal Cancer
• Carcinoma of the Vulva

Interventions

Type	Name	Description
PROCEDURE	Image-guided brachytherapy	MRI-guided application of brachytherapy
DRUG	3'-Deoxy-3'-18f-Fluorothymidine	Assessing tumor proliferation in Gynecologic cancer

Timeline

• Start date: 2011-09-01
• Primary completion: 2016-02-01
• Completion: 2016-06-01
• First posted: 2011-07-22
• Last updated: 2023-03-14
• Results posted: 2022-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study