NCT02993900Recruiting
Image-Guided Gynecologic Brachytherapy
A Clinical Trial To Evaluate Image-Guided Gynecologic Brachytherapy In The MR Simulator Suite
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 30 Nov 2016
- Start date
- 15 Dec 2016
- Primary completion date
- Dec 2026
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Bladder cancer, Cervical cancer
- NCT number
- NCT02993900
What you commit to
- Study type: Interventional
- Planned participants: 54
- From 15 Dec 2016 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- A history of metal in the head or eyes
Lab values
- Absolute neutrophil count \< 500 at the time of enrollment
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The SKCCC at Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.