Recruiting

Brachytherapy

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT02993900

Conditions

Cervical Cancer

Uterine Cancer

Vaginal Cancer

Vulvar Cancer

Bladder Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Image-Guided Brachytherapy

Study Details

Brief summary:

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.

Conditions

Cervical Cancer

Uterine Cancer

Vaginal Cancer

Vulvar Cancer

Bladder Cancer

Study ID

NCT02993900

Start date

Dec 15, 2016

Status verified date

Dec, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

54 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Image-Guided Brachytherapy

Magnetic Resonance Imaging (MRI) guided brachytherapy Procedure: Image-Guided Brachytherapy

Interventions

Image-Guided Brachytherapy

Brachytherapy will be precisely inserted with the assistance of magnetic resonance (MRI) scans

Primary outcome measure

  • Dosing changes [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Shirley DiPasquale, R.N.

410-614-1598sdipasq1@jhmi.edu

Locations

The SKCCC at Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Shirl DiPasquale, R.N.

410-614-1598sdipasq1@jhmi.edu

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2025-12-18.