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Trial record 1 of 5 for:    AMIGO | Brigham and Womens
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Image-Guided Gynecologic Brachytherapy (AMIGO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01399658
Recruitment Status : Active, not recruiting
First Posted : July 22, 2011
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Larissa Lee, MD, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE July 8, 2011
First Posted Date  ICMJE July 22, 2011
Last Update Posted Date March 5, 2020
Study Start Date  ICMJE September 2011
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2011)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Image-Guided Gynecologic Brachytherapy
Official Title  ICMJE A Clinical Trial to Evaluate Image-Guided Gynecologic Brachytherapy in the Advanced Multimodality Image-Guided Operating Suite (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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cervical Cancer
  • Uterine Cancer
  • Vaginal Cancer
  • Carcinoma of the Vulva
Intervention  ICMJE Procedure: Image-guided brachytherapy
MRI-guided application of brachytherapy
Study Arms  ICMJE Experimental: Image-Guided Brachytherapy
Image-guided brachytherapy
Intervention: Procedure: Image-guided brachytherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 9, 2016)
93
Original Estimated Enrollment  ICMJE
 (submitted: July 20, 2011)
24
Estimated Study Completion Date  ICMJE June 2021
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01399658
Other Study ID Numbers  ICMJE 11-098
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Larissa Lee, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Larissa Lee, MD Brigham and Women's Hospital
PRS Account Dana-Farber Cancer Institute
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP