Optimizing Brachytherapy Application and Delivery With MRI Guidance for Gynecologic Cancer

Description

The aim of this study is to develop new tools using magnetic resonance imaging (MRI) that will improve the brachytherapy procedure and treatment for participants with gynecologic cancer.

Study Start Date

October, 31 2017

Estimated Completion Date

September 2027

Interventions

  • Device: MRI
  • Device: MRI Tracker
  • Radiation: Brachytherapy

Study ID

Dana-Farber Cancer Institute -- 17-128

Status

Recruiting

Trial ID

NCT03277469

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

100

Sponsor

Dana-Farber Cancer Institute

Inclusion Criteria

  • Ability to understand and the willingness to sign a written informed consent document. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • Participants must have a biopsy-proven diagnosis of primary or recurrent gynecologic cancer for which intracavitary or interstitial brachytherapy is planned as standard treatment. Eligible disease sites include primary or recurrent cancer of endometrial, ovarian, cervical, vaginal, or vulvar origin.
  • Age of 18 years or older are eligible.
  • ECOG performance status of 2 or less.
  • Patients who have received prior radiation or chemotherapy may be enrolled on this study.
  • Participant is deemed to be an appropriate candidate for MRI-guided brachytherapy by the radiation oncologist and the patient elects to be treated with MRI-guided brachytherapy.
  • Participant provides informed consent for prospective collection of relevant medical records for analysis of clinical outcome and treatment-planning techniques.

Exclusion Criteria

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, interstitial lung disease, active peptic ulcer disease or gastritis, active bleeding diatheses, serious chronic gastrointestinal conditions associated with diarrhea or psychiatric illness/social situations that would limit compliance with study requirements.
  • Contraindication to MRI identified by the MR procedure screening form, such as a pacemaker, aneurysm clip, inner ear implant, neurostimulator, or other non-MR compatible implant or device.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (5)

Study Location Distance Name Phone Email
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Teresa Cheng MPH 617-732-8421 Teresa_Cheng@DFCI.HARVARD.EDU
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Teresa Cheng MPH 617-732-8421 Teresa_Cheng@DFCI.HARVARD.EDU
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Teresa Cheng MPH 617-732-8421 Teresa_Cheng@DFCI.HARVARD.EDU
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Teresa Cheng MPH 617-732-8421 Teresa_Cheng@DFCI.HARVARD.EDU
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Teresa Cheng MPH 617-732-8421 Teresa_Cheng@DFCI.HARVARD.EDU

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