Image-Guided Gynecologic Brachytherapy (AMIGO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 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: February 13, 2014
Last verified: February 2014

July 8, 2011
February 13, 2014
September 2011
July 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01399658 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Image-Guided Gynecologic Brachytherapy
A Clinical Trial to Evaluate Image-Guided Gynecologic Brachytherapy in the Advanced Multimodality Image-Guided Operating Suite (AMIGO)

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cervical Cancer
  • Uterine Cancer
  • Vaginal Cancer
  • Carcinoma of the Vulva
Procedure: Image-guided brachytherapy
MRI-guided application of brachytherapy
Experimental: Image-Guided Brachytherapy
Image-guided brachytherapy
Intervention: Procedure: Image-guided brachytherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
July 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Akila N Viswanathan, M.D., M.P.H. 617-732-6331 aviswanathan@lroc.harvard.edu
United States
 
NCT01399658
11-098
Yes
Akila N. Viswanathan, MD, MPH, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Not Provided
Principal Investigator: Akila N Viswanathan, M.D., M.P.H. Brigham and Women's Hospital
Dana-Farber Cancer Institute
February 2014

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