Back to resultsImage-Guided Gynecologic Brachytherapy (AMIGO)
Primary Purpose
Cervical Cancer, Uterine Cancer, Vaginal Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Image-guided brachytherapy
3'-Deoxy-3'-18f-Fluorothymidine
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring Brachytherapy, Gynecological cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed carcinoma of the cervix (Stage I-IVA), carcinoma of the uterus (Stage IIIB), carcinoma of the vagina (Stage I-IVA), or carcinoma of the vulva (stage I-IVA)
- Life expectancy > 6 months
- MRI of the pelvis and/or PET-CT within 4 months prior to entering study
Exclusion Criteria:
- Uncontrolled intercurrent illness
- Pacemaker, brain aneurysm clip, inner ear implant, neurostimulator, or metal fragments in the eye
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Image-Guided Brachytherapy
Arm Description
Image-guided brachytherapy
Outcomes
Primary Outcome Measures
Mean Doses Given
Doses given to the tumor, rectum, and sigmoid obtained after AMIGO-guided placement.
Secondary Outcome Measures
Full Information
NCT ID
NCT01399658
First Posted
July 8, 2011
Last Updated
March 13, 2023
Sponsor
Dana-Farber Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT01399658
Brief Title
Image-Guided Gynecologic Brachytherapy
Acronym
AMIGO
Official Title
A Clinical Trial to Evaluate Image-Guided Gynecologic Brachytherapy in the Advanced Multimodality Image-Guided Operating Suite (AMIGO)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Uterine Cancer, Vaginal Cancer, Carcinoma of the Vulva
Keywords
Brachytherapy, Gynecological cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Image-Guided Brachytherapy
Arm Type
Experimental
Arm Description
Image-guided brachytherapy
Intervention Type
Procedure
Intervention Name(s)
Image-guided brachytherapy
Other Intervention Name(s)
internal radiation therapy, implant radiation
Intervention Description
MRI-guided application of brachytherapy
Intervention Type
Drug
Intervention Name(s)
3'-Deoxy-3'-18f-Fluorothymidine
Intervention Description
Assessing tumor proliferation in Gynecologic cancer
Primary Outcome Measure Information:
Title
Mean Doses Given
Description
Doses given to the tumor, rectum, and sigmoid obtained after AMIGO-guided placement.
Time Frame
Measured while on treatment, up to 2 months.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed carcinoma of the cervix (Stage I-IVA), carcinoma of the uterus (Stage IIIB), carcinoma of the vagina (Stage I-IVA), or carcinoma of the vulva (stage I-IVA)
Life expectancy > 6 months
MRI of the pelvis and/or PET-CT within 4 months prior to entering study
Exclusion Criteria:
Uncontrolled intercurrent illness
Pacemaker, brain aneurysm clip, inner ear implant, neurostimulator, or metal fragments in the eye
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin King, MD, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Image-Guided Gynecologic Brachytherapy
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