Image-Guided Gynecologic Brachytherapy for Gynecologic Cancers

This study is testing a treatment called Image-Guided Brachytherapy for women aged 18 to 100 with cervical, uterine, vaginal, vulvar, or bladder cancer. Brachytherapy is a type of radiation therapy where a device is placed inside or near the tumor. In this study, magnetic resonance imaging (MRI) scans will be used to precisely guide the placement of this device. Researchers want to see if using MRI guidance can better assess the tumor and potentially reduce the radiation dose to healthy tissues compared to standard CT scans. The main goal is to see how changes in radiation dosing affect patients over three years. The study is currently unclear on its recruitment status.

Study design: This is an interventional study planning to enroll 54 women. It is not specified if it is randomized or blinded.
What's involved: You would receive Image-Guided Brachytherapy, which involves the precise insertion of a brachytherapy device with MRI assistance. The study will compare CT versus MRI planning.
Compensation: Not stated in the trial record.
Follow-up: Researchers will compare toxicity rates at 6 months, 1 year, and 2 years after treatment. Dosing changes will be measured at 3 years.

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Image-Guided Gynecologic Brachytherapy

Recruiting

NAAges 18+InterventionalTreatment

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

~54 participants

Updated 2025-12-18 on ClinicalTrials.gov

What's tested:Image-Guided Brachytherapy

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Dosing changes

Measured over 3 years

Conditions

Cervical Cancer

Uterine Cancer

Vaginal Cancer

Vulvar Cancer

Bladder Cancer

Where it's being run

1 sites across 1 states

Maryland1

Study leadership

Akila Viswanathan, M.D. · PRINCIPAL_INVESTIGATOR · Johns Hopkins Department of Radiation Oncology

Who to contact

Shirley DiPasquale, R.N.

[email protected]

410-614-1598

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

Dosing changes3 years
To quantify the relative reduction of dose to rectum, sigmoid and bladder obtained after MR Simulator Suite-guided placement, as compared to standard CT guided treatment based on historical information and literature review.

Trialytics