Optimizing Brachytherapy Application and Delivery with MRI Guidance for Gynecologic Cancer

NOT ENROLLING
Protocol # :
17-128
Conditions
Gynecologic Cancer
Phase
II
Disease Sites
Cervix
Corpus Uteri
Ovary
Other Female Genital
Prostate
Other Male Genital
Principal Investigator
King, Martin, T
Site Investigator
Lee, Larissa, J.
Site Research Nurses
Mann, Eileen, Marie
Spicer, Beverly, A.

Trial 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.

Eligibility Requirements

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.

17-128