Image-Guided Gynecologic Brachytherapy

NCT02993900 | Recruiting DMC

• 3 other identifiers: J1660IRB00098525R21CA167800
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The rate of treatment-related toxicity

  3 months, 6 months and 1 year

• Time to local failure

  1 year and 2 year

• Rate of survival

  1 year and 2 year

Study Arms (1)

Image-Guided Brachytherapy

EXPERIMENTAL

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

Device: Image-Guided Brachytherapy

Interventions

Image-Guided Brachytherapy DEVICE

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

Image-Guided Brachytherapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

The SKCCC at Johns Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Neoplasms; Vaginal Neoplasms; Vulvar Neoplasms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vaginal Diseases; Vulvar Diseases; Urologic Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Akila Viswanathan, M.D.

  Johns Hopkins Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shirley DiPasquale, R.N.

CONTACT

410-614-1598; sdipasq1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 15, 2016
• Study Start: December 15, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)