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

Tracking Information

First Received Date ^ICMJE

July 8, 2011

Last Updated Date

January 15, 2013

Start Date ^ICMJE

September 2011

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01399658 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Arm (s)

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

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

July 2014 (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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Akila N Viswanathan, M.D., M.P.H.

617-732-6331

aviswanathan@lroc.harvard.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01399658

Other Study ID Numbers ^ICMJE

11-098

Has Data Monitoring Committee

Yes

Responsible Party

Akila N. Viswanathan, MD, MPH, Dana-Farber Cancer Institute

Study Sponsor ^ICMJE

Dana-Farber Cancer Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Akila N Viswanathan, M.D., M.P.H.

Brigham and Women's Hospital

Information Provided By

Dana-Farber Cancer Institute

Verification Date

January 2013

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

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