Image-Guided Gynecologic Brachytherapy

Recruiting now · Not applicable

Conditions studied: Cervical Cancer, Uterine Cancer, Vaginal Cancer, Vulvar Cancer, Bladder Cancer

In brief

This research is being done to evaluate multimodality imaging, including magnetic resonance imaging-guided therapy (MRT), as a possible treatment for gynecologic cancers. The therapy takes place in the Department of Radiation Oncology at the Johns Hopkins SKCCC. The purpose of this study is to investigate the ability of MRI to successfully guide the placement of the brachytherapy applicator necessary to treat participants' gynecologic cancer. The Investigators want to see if the use of MRI will do a better job of assessing the tumor at the time of brachytherapy than the routinely used CT scan. The Investigators also want to determine if the use of MRI will enable doctors to reduce the radiation dose received by the body during the process of treating the tumor.

Key facts

Study ID

NCT02993900

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

54

Starts

2016-12-15

Expected to finish

2028-12-01

Last updated by the study team

2025-12-18

Who can join

Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have histologically or cytologically confirmed carcinoma. Central pathology review is not required; however, pathology will be reviewed at the SKCCC at Johns Hopkins.
• Site/Stage
• Any patient eligible for internal implantation without MR guidance will be considered eligible for this protocol. Standard criteria for internal implantation include:
• Carcinoma of the cervix: Stage I-IVA or vaginal recurrence
• Carcinoma of the uterus: Stage IIIB (vaginal involvement), inoperable, or vaginal recurrence
• Carcinoma of the vagina: Stage I-IVA or vaginal recurrence
• Carcinoma of the vulva: Stage I-IVA or recurrence
• Carcinoma of the urethra based on treating physician's discretion
• Patients who have received prior radiation or chemotherapy may be enrolled on this study.
• Age > 18 years. Children do not develop these malignancies and therefore are not considered candidates for this trial.
• Life expectancy of greater than 6 months.
• ECOG performance status of <2 or greater, based on treating physician's discretion
• MRI of the pelvis or PET-CT within 4 months before registration
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Absolute neutrophil count < 500 at the time of enrollment
• A history of metal in the head or eyes

Where it is running

• The SKCCC at Johns Hopkins — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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