Using MRI to improve gynecologic cancer treatment with brachytherapy

A Clinical Trial To Evaluate Image-Guided Gynecologic Brachytherapy In The MR Simulator Suite

This study is testing if using MRI instead of traditional CT scans can help improve brachytherapy treatment for women with gynecologic cancers by better targeting tumors and reducing radiation exposure to healthy tissues.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 18 Years to 100 Years
• Sex: Female
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT02993900 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with confirmed gynecologic cancers eligible for internal brachytherapy implantation.

Not a fit: Patients with early-stage cancers that do not require brachytherapy or those with a life expectancy of less than 6 months may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and safer treatment options for patients with gynecologic cancers.

How similar studies have performed: Other studies have shown promising results using MRI for treatment planning in radiation therapy, suggesting potential success for this approach.

Eligibility criteria

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 this trial is running

Baltimore, Maryland

• 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.

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