Image-Guided Gynecologic Brachytherapy

  • STATUS
    Recruiting
  • End date
    Dec 25, 2024
  • participants needed
    54
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 25 March 2022
ct scan
cancer
carcinoma
MRI
brachytherapy
primary cancer
pet/ct scan
gynecologic cancer
cervical carcinoma
cancer of the cervix
carcinoma of the uterus
vaginal carcinoma
vulvar carcinoma

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.

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.

Details
Condition Cervical Cancer, Uterine Cancer, Vaginal Cancer, Vulvar Cancer, Bladder Cancer
Treatment Image-Guided Brachytherapy
Clinical Study IdentifierNCT02993900
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

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
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