Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-02-25 @ 6:59 PM
Study NCT ID:
NCT01399658
Status:
COMPLETED
Last Update Posted:
2023-03-14
First Post:
2011-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Image-Guided Gynecologic Brachytherapy
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
A Clinical Trial to Evaluate Image-Guided Gynecologic Brachytherapy in the Advanced Multimodality Image-Guided Operating Suite (AMIGO)
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMIGO
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: