Image-Guided Gynecologic Brachytherapy (AMIGO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Akila N. Viswanathan, MD, MPH, Dana-Farber Cancer Institute Identifier:
First received: July 8, 2011
Last updated: July 30, 2015
Last verified: July 2015
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 Intervention Phase
Cervical Cancer
Uterine Cancer
Vaginal Cancer
Carcinoma of the Vulva
Procedure: Image-guided brachytherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Dose determination [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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:
  • Toxicities: gastrointestinal, genitourinary, and skin [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    • 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.

Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Image-Guided Brachytherapy
Image-guided brachytherapy
Procedure: Image-guided brachytherapy
MRI-guided application of brachytherapy

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.


Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01399658

Contact: Akila N Viswanathan, M.D., M.P.H. 617-732-6331

United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Akila N Viswanathan, MD MPH    617-732-6331      
Principal Investigator: Akila N Viswanathan, M.D., M.P.H.         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Principal Investigator: Akila N Viswanathan, M.D., M.P.H. Brigham and Women's Hospital
  More Information

Responsible Party: Akila N. Viswanathan, MD, MPH, Director, Gynecologic Radiation Oncology, Dana-Farber Cancer Institute Identifier: NCT01399658     History of Changes
Other Study ID Numbers: 11-098 
Study First Received: July 8, 2011
Last Updated: July 30, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Gynecological cancer

Additional relevant MeSH terms:
Vaginal Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Vulvar Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Vaginal Diseases
Vulvar Diseases processed this record on May 23, 2016