Image-Guided Gynecologic Brachytherapy

December 16, 2025 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of this trial is to assess how magnetic resonance imaging (MRI) may be used to improve tumor and normal tissue volume delineation, reducing toxicity and recurrence in gynecologic brachytherapy. The Investigators will compare dosimetric values to the organs at risk (OAR) with CT versus MRI planning. The Investigators anticipate that MR-planned cases will have lower OAR doses than standard CT-based cases due to more conformal planning. The Investigators will determine dose thresholds for radiation-related toxicity after treatment. The Investigators will compare toxicity rates at 6 months, 1 and 2 years after treatment, thereby enabling improved recommendations on dose limits to the OAR.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • The SKCCC at Johns Hopkins
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Image-Guided Brachytherapy
Magnetic Resonance Imaging (MRI) guided brachytherapy Procedure: Image-Guided Brachytherapy
Device: Image-Guided Brachytherapy
Brachytherapy will be precisely inserted with the assistance of magnetic resonance (MRI) scans

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dosing changes
Time Frame: 3 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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of treatment-related toxicity
Time Frame: 3 months, 6 months and 1 year
To determine the rate of treatment-related toxicity within 3 months, 6 months and 1 year after MR Simulator Suite-guided placement.
3 months, 6 months and 1 year
Time to local failure
Time Frame: 1 year and 2 year
To determine the local failure rates at 1 year and 2 year after MR Simulator Suite-guided placement.
1 year and 2 year
Rate of survival
Time Frame: 1 year and 2 year
To determine the overall survival rates at 1 year and 2 year after MR Simulator Suite-guided placement.
1 year and 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Akila Viswanathan, M.D., Johns Hopkins Department of Radiation Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

November 30, 2016

First Submitted That Met QC Criteria

December 14, 2016

First Posted (Estimated)

December 15, 2016

Study Record Updates

Last Update Posted (Estimated)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J1660
  • IRB00098525 (Other Identifier: JHM IRB)
  • R21CA167800 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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