Actively Recruiting
A Clinical Trial To Evaluate Image-Guided Gynecologic Brachytherapy In The MR Simulator Suite
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-12-18
54
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of magnetic resonance imaging (MRI) to guide brachytherapy treatment in gynecologic cancers such as cervical, uterine, vaginal, vulvar, and bladder cancers. This study aims to determine if MRI can more accurately assess tumors during brachytherapy compared to the commonly used CT scans, potentially improving treatment precision and reducing radiation exposure to healthy tissues. The goal is to improve how doctors plan radiation doses and reduce treatment-related side effects. The study involves using MRI-guided brachytherapy, where MRI scans help precisely place the radiation applicator to target the tumor. Investigators will compare radiation doses to organs at risk during MRI-based planning versus standard CT-based planning. The study will assess radiation dose thresholds that may cause toxicity and compare toxicity rates at 6 months, 1 year, and 2 years after treatment to improve future dose recommendations. Participants will undergo MRI scans to guide their brachytherapy treatment and will be monitored for treatment-related side effects and tumor control over time. Researchers will measure changes in radiation dosing over 3 years and track toxicity rates, local tumor failure, and survival at various intervals up to 2 years. The total participation duration includes treatment and follow-up monitoring to evaluate the safety and effectiveness of MRI-guided brachytherapy.
CONDITIONS
Brief Title
Image-Guided Gynecologic Brachytherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have confirmed carcinoma by tissue or cell examination.
- Eligible cancer types include cervical (Stage I-IVA or vaginal recurrence), uterine (Stage IIIB with vaginal involvement, inoperable, or vaginal recurrence), vaginal (Stage I-IVA or vaginal recurrence), vulvar (Stage I-IVA or recurrence), or urethra carcinoma as decided by the doctor.
- Patients who have had prior radiation or chemotherapy may join.
- Age must be over 18 years.
- Life expectancy must be greater than 6 months.
- ECOG performance status must be less than 2 or as determined by the doctor.
- Must have had an MRI of the pelvis or PET-CT within 4 months before joining.
- Must be able to understand and willing to sign informed consent.
You will not qualify if you...
- Having uncontrolled illness such as active infection, heart failure, unstable angina, irregular heartbeat, or psychiatric issues that prevent following study rules.
- Absolute neutrophil count below 500 at enrollment.
- History of metal in the head or eyes.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of treatment procedure
Participants undergo image-guided brachytherapy where brachytherapy is precisely inserted with the assistance of magnetic resonance (MRI) scans.
1 treatment visit (in-person)
Duration - Up to 2 years
Participants are monitored for treatment-related toxicity, local failure, and survival over time after the brachytherapy treatment.
Visits at 3 months, 6 months, 1 year, and 2 years post-treatment
Trial Site Locations
Total: 1 location
1
The SKCCC at Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
S
Shirley DiPasquale, R.N.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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