Clinical trial · Interventional
Optimizing Brachytherapy Application and Delivery With MRI Guidance for Gynecologic Cancer
NCT03277469CI-TRIAL-00109061active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to develop new tools using magnetic resonance imaging (MRI) that will improve the brachytherapy procedure and treatment for participants with gynecologic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy | Radiation | — | UNRESOLVED |
| MRI | Device | — | UNRESOLVED |
| MRI Tracker | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MRI Guided BRACHYTHERAPY with Tracker
- description
- * Standard pelvic MRI sequences will be obtained * MRI Tracker is used during catheter positioning with serial MR imaging during implant * All patients will undergo 3D-based image acquisition for brachytherapy treatment planning per standard clinical practice * The brachytherapy modality to be used is high-dose-rate brachytherapy using an iridum-192 stepping source
- interventionNames
- Device: MRI
- Radiation: Brachytherapy
- Device: MRI Tracker
- type
- EXPERIMENTAL
- label
- MRI Guided BRACHYTHERAPY without Tracker
- description
- * Standard pelvic MRI sequences will be obtained * Standard process is used with serial MR imaging to evaluate catheter position during implant * All patients will undergo 3D-based image acquisition for brachytherapy treatment planning per standard clinical practice * The brachytherapy modality to be used is high-dose-rate brachytherapy using an iridum-192 stepping source
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent document. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. * Participants must have a biopsy-proven diagnosis of primary or recurrent gynecologic cancer for which intracavitary or interstitial brachytherapy is planned as standard treatment. Eligible disease sites include primary or recurrent cancer of endometrial, ovarian, cervical, vaginal, or vulvar origin. * Age of 18 years or older are eligible. * ECOG performance status of 2 or less. * Patients who have received prior radiation or chemotherapy may be enrolled on this study. * Participant is deemed to be an appropriate candidate for MRI-guided brachytherapy by the radiation oncologist and the patient elects to be treated with MRI-guided brachytherapy. * Participant provides informed consent for prospective collection of relevant medical records for analysis of clinical outcome and treatment-planning techniques. Exclusion Criteria: * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, interstitial lung disease, active peptic ulcer disease or gastritis, active bleeding diatheses, serious chronic gastrointestinal conditions associated with diarrhea or psychiatric illness/social situations that would limit compliance with study requirements. * Contraindication to MRI identified by the MR procedure screening form, such as a pacemaker, aneurysm clip, inner ear implant, neurostimulator, or other non-MR compatible implant or device.
References
Publications (0)
Data not yet available
No reference posted for this study.