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Image-Guided Gynecologic Brachytherapy (AMIGO)

This study is currently recruiting participants.
Verified January 2013 by Dana-Farber Cancer Institute
Sponsor:
Information provided by (Responsible Party):
Akila N. Viswanathan, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01399658
First received: July 8, 2011
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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: 50
Study Start Date: September 2011
Estimated Primary Completion Date: July 2014 (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 FLT-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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399658

Contacts
Contact: Akila N Viswanathan, M.D., M.P.H. 617-732-6331 aviswanathan@lroc.harvard.edu

Locations
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
Investigators
Principal Investigator: Akila N Viswanathan, M.D., M.P.H. Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Akila N. Viswanathan, MD, MPH, Director, Gynecologic Radiation Oncology, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01399658     History of Changes
Other Study ID Numbers: 11-098
Study First Received: July 8, 2011
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Brachytherapy
Gynecological cancer

Additional relevant MeSH terms:
Carcinoma
Uterine Cervical Neoplasms
Uterine Neoplasms
Vaginal Neoplasms
Vulvar Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Vaginal Diseases
Vulvar Diseases

ClinicalTrials.gov processed this record on May 21, 2013