Clinical trial · Observational
Brachytherapy Innovations in Gynecologic Cancer
Magnetic Resonance-Guided Brachytherapy Innovations in Gynecologic Cancer-Methods to Identify Remnant Tumor Versus Scar Tissue in Relation to Radiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study never opened.
Summary
Brief summary (as posted)
In this pilot study, the investigators will test tools designed to more precisely identify, define and create a radiation treatment plan to tumor remnants as separate from fibrotic or normal tissue in a Magnetic Resonance (MR) simulator in the department of radiation oncology. The investigators will examine if this beneficial for tumor versus normal tissue delineation, will result in more precise tumor targeting with radiation in an efficient manner and whether there would be fewer toxicities.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- MR Group
- description
- Following standard MRI-guided Brachytherapy, patients will have images analyzed for quantification of residual tumor versus fibrosis. We will pilot-test an endovaginal coil, a deflectable MR stylet, real-time planning software, and auto-segmentation of normal and tumor tissue.
Primary outcomes (1)
- measure
- Toxicity rates calculated for patients enrolled on this study
- timeFrame
- Up to 24 months post treatment
- description
- Toxicity rates will be calculated using the Common Terminology Criteria for Adverse Events (CTCAE v. 4.0)
Secondary outcomes (1)
- measure
- Change in tumor as assessed by MRI
- timeFrame
- Prior to treatment/at diagnosis and post-brachytherapy treatment up to 14 days
- description
- Compare changes in tumor based on MRI.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Participants must meet the following criteria on screening examination to be eligible to participate in the study: * Participants must have histologically or cytologically confirmed carcinoma. Central pathology review is not required; however, pathology will be reviewed at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins. * 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. * Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG status of \<2, based on treating physician's discretion * 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 brachytherapy * A history of metal in the head or eyes
References
Publications (0)
Data not yet available