Brief Title
Image-Guided Gynecologic Brachytherapy
Official Title
A Clinical Trial To Evaluate Image-Guided Gynecologic Brachytherapy In The MR Simulator Suite
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.
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
Primary Outcome
Dosing changes
Secondary Outcome
The rate of treatment-related toxicity
Condition
Cervical Cancer
Intervention
Image-Guided Brachytherapy
Study Arms / Comparison Groups
Image-Guided Brachytherapy
Description: Magnetic Resonance Imaging (MRI) guided brachytherapy Procedure: Image-Guided Brachytherapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
54
Start Date
December 15, 2016
Completion Date
December 2024
Primary Completion Date
December 2022
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
Gender
Female
Ages
18 Years - 100 Years
Accepts Healthy Volunteers
No
Contacts
Akila Viswanathan, M.D., 410-614-1598, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02993900
Organization ID
J1660
Secondary IDs
IRB00098525
Responsible Party
Sponsor
Study Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Akila Viswanathan, M.D., Principal Investigator, Johns Hopkins Department of Radiation Oncology
Verification Date
January 2022