Image-Guided Gynecologic Brachytherapy

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: Cervical Cancer; Vulvar Cancer; Bladder Cancer; Vaginal Cancer; Uterine Cancer
• Intervention / Treatment: Device: Image-Guided Brachytherapy

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

• Study Contact: Name: Shirley DiPasquale, R.N.; Phone Number: 410-614-1598; Email: sdipasq1@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • The SKCCC at Johns Hopkins
      • Contact: Shirl DiPasquale, R.N.; Phone Number: 410-614-1598; Email: sdipasq1@jhmi.edu

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	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	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	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

• 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

Study Major Dates

• Study Start (Actual): December 15, 2016
• Primary Completion (Estimated): December 1, 2025
• 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 (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Diseases; Vaginal Diseases; Vulvar Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vulvar Neoplasms; Vaginal Neoplasms; Uterine Neoplasms
• 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