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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
United States
Maryland
The SKCCC at Johns Hopkins
RECRUITING
Baltimore
Contact Information
Primary
Shirley DiPasquale, R.N.
sdipasq1@jhmi.edu
410-614-1598
Time Frame
Start Date: 2016-12-15
Estimated Completion Date: 2028-12
Participants
Target number of participants: 54
Treatments
Experimental: Image-Guided Brachytherapy
Magnetic Resonance Imaging (MRI) guided brachytherapy Procedure: Image-Guided Brachytherapy
Sponsors
Collaborators: National Cancer Institute (NCI)
Leads: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

This content was sourced from clinicaltrials.gov

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