Optimizing Brachytherapy Application and Delivery With MRI Guidance for Gynecologic Cancer

Not Applicable

Active, not recruiting

• Conditions: Gynecologic Cancer

• Registration Number: NCT03277469
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-9-7
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 49

Inclusion Criteria

Inclusion Criteria:<br><br> - Ability to understand and the willingness to sign a written informed consent<br> document. Subject is willing and able to comply with the protocol for the duration<br> of the study including undergoing treatment and scheduled visits and examinations<br> including follow up.<br><br> - Participants must have a biopsy-proven diagnosis of primary or recurrent gynecologic<br> cancer for which intracavitary or interstitial brachytherapy is planned as standard<br> treatment. Eligible disease sites include primary or recurrent cancer of<br> endometrial, ovarian, cervical, vaginal, or vulvar origin.<br><br> - Age of 18 years or older are eligible.<br><br> - ECOG performance status of 2 or less.<br><br> - Patients who have received prior radiation or chemotherapy may be enrolled on this<br> study.<br><br> - Participant is deemed to be an appropriate candidate for MRI-guided brachytherapy by<br> the radiation oncologist and the patient elects to be treated with MRI-guided<br> brachytherapy.<br><br> - Participant provides informed consent for prospective collection of relevant medical<br> records for analysis of clinical outcome and treatment-planning techniques.<br><br>Exclusion Criteria:<br><br> - Uncontrolled intercurrent illness including, but not limited to, ongoing or active<br> infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac<br> arrhythmia, uncontrolled hypertension, interstitial lung disease, active peptic<br> ulcer disease or gastritis, active bleeding diatheses, serious chronic<br> gastrointestinal conditions associated with diarrhea or psychiatric illness/social<br> situations that would limit compliance with study requirements.<br><br> - Contraindication to MRI identified by the MR procedure screening form, such as a<br> pacemaker, aneurysm clip, inner ear implant, neurostimulator, or other non-MR<br> compatible implant or device.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brachytherapy treatment parameters, including V150

Secondary Outcome Measures

Name	Time	Method
Local-Failure-Free Survival;Progression Free Survival;Overall Survival