Health TrialsbyHealthPanel

Image-Guided Gynecologic Brachytherapy

ConditionsCervical CancerUterine CancerVaginal CancerVulvar CancerBladder Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-100
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Carcinoma of the cervix: Stage I-IVA or vaginal recurrence

Carcinoma of the uterus: Stage IIIB (vaginal involvement), inoperable, or vaginal recurrence

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Image-Guided Brachytherapy

    Device

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

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: Image-Guided BrachytherapyExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
3 years

Secondary outcomes

1

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.

Time frame
3 months, 6 months and 1 year
2

Time to local failure

To determine the local failure rates at 1 year and 2 year after MR Simulator Suite-guided placement.

Time frame
1 year and 2 year
3

Rate of survival

To determine the overall survival rates at 1 year and 2 year after MR Simulator Suite-guided placement.

Time frame
1 year and 2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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