Using MRI to improve gynecologic cancer treatment with brachytherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research evaluates the use of magnetic resonance imaging (MRI) to guide brachytherapy for patients with gynecologic cancers, including cervical, uterine, vaginal, vulvar, and bladder cancers. The study aims to determine if MRI can provide better tumor assessment and placement of the brachytherapy applicator compared to traditional CT scans. By comparing dosimetric values and toxicity rates, the investigators hope to reduce radiation exposure to healthy tissues while improving treatment outcomes. Participants will be monitored for toxicity rates at 6 months, 1 year, and 2 years post-treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• The SKCCC at Johns Hopkins
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Akila Viswanathan, M.D. — Johns Hopkins Department of Radiation Oncology
• Study coordinator: Shirley DiPasquale, R.N.
• Email: sdipasq1@jhmi.edu
• Phone: 410-614-1598

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.