MRI-Guided radiation may spare healthy organs in gynecologic cancer treatment
NCT ID NCT02993900
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether using MRI scans to guide brachytherapy (a type of internal radiation) can better target tumors in gynecologic cancers like cervical, uterine, vaginal, vulvar, and bladder cancers. The goal is to see if MRI guidance reduces radiation exposure to nearby healthy organs like the bladder and rectum compared to standard CT guidance. About 54 participants will be enrolled, and researchers will track side effects and cancer control over two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Image-guided brachytherapy (radiation therapy placed with MRI guidance)
- What this could lead to
- If successful, this could make brachytherapy more precise, reducing side effects by lowering radiation exposure to the bladder and rectum.
- What could go wrong
- This is a small, early-phase study (54 participants) comparing MRI guidance to historical CT data, so results may not be definitive or widely applicable.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2016
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The SKCCC at Johns Hopkins
RECRUITINGBaltimore, Maryland, 21287, United States
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Other studies related to the condition(s) this trial covers.
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- Lab-Grown tumor models could match patients to the right cancer drug
- Can a new vaginal scanner map tumors and cut MRI reliance?