Status:
ACTIVE_NOT_RECRUITING
Optimizing Brachytherapy Application and Delivery With MRI Guidance for Gynecologic Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Gynecologic Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
This research study is designed to develop new technology using MR imaging to improve the brachytherapy procedure for participants with gynecologic cancer. The brachytherapy procedure will take place ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2027
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03277469
Start Date
November 13 2017
End Date
September 15 2027
Last Update
October 31 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115