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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. Identifier: NCT01399658
Recruitment Status : Active, not recruiting
First Posted : July 22, 2011
Last Update Posted : March 5, 2020
Information provided by (Responsible Party):
Larissa Lee, MD, Dana-Farber Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Uterine Cancer Vaginal Cancer Carcinoma of the Vulva Procedure: Image-guided brachytherapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Image-Guided Brachytherapy
Image-guided brachytherapy
Procedure: Image-guided brachytherapy
MRI-guided application of brachytherapy

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01399658

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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
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Principal Investigator: Larissa Lee, MD Brigham and Women's Hospital
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Responsible Party: Larissa Lee, MD, Prinicipal Investigator, Dana-Farber Cancer Institute Identifier: NCT01399658    
Other Study ID Numbers: 11-098
First Posted: July 22, 2011    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Larissa Lee, MD, Dana-Farber Cancer Institute:
Gynecological cancer
Additional relevant MeSH terms:
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Vaginal Neoplasms
Uterine Neoplasms
Vulvar Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Vaginal Diseases
Vulvar Diseases