Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Gynecologic Cancer
Type
Observational
Design
Observational Model: OtherTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 80 years
Gender
Only males

Description

This study is a clinical research study following patients for toxicity after brachytherapy, and the investigators will be using the D2cc as a surrogate biomarker for determining risk for toxicity in addition to utilizing toxicity measured from physician-queries using the Common Toxicity Criteria fo...

This study is a clinical research study following patients for toxicity after brachytherapy, and the investigators will be using the D2cc as a surrogate biomarker for determining risk for toxicity in addition to utilizing toxicity measured from physician-queries using the Common Toxicity Criteria for Adverse Events (CTCAE v. 4.0). Patients will have images analyzed for quantification of residual tumor versus fibrosis. The investigators will utilize Magnetic Resonance (MR) tracking, and pilot test: an endovaginal coil, a deflectable Magnetic Resonance stylet, real-time planning software, and auto-segmentation of normal tissues and tumor. Standard T2-weighted MR images are generally recommended given the soft-tissue visualization without the need for contrast media injection. At the time of brachytherapy, acquisition of para-axial, para-sagittal and para-coronal images should be performed with the orientations being orthogonal (para-axial) and parallel (para-sagittal/para-coronal) to the intrauterine tandem. Slice thickness has a direct impact on applicator reconstruction accuracy, and a slice thickness of ?3mm is required on the NRG Oncology study (NRG-GY006). More advanced multi-parametric magnetic resonance imaging (mmpMRI) series show significant promise. A Dynamic Contrast Enhanced (DCE) study identified one voxel cluster consisting of low-enhancing voxels based on the relative signal increase (RSI) time series that was related to locoregional control (adjusted p-value 0.048). Diffusion-weighted (DW)-MRI is used to identify areas of dense residual tumor.31 In one analysis, the mean apparent diffusion coefficient (ADC) value of the primary tumor on pretreatment MRI was an independent predictor of disease-free survival in cervical cancer patients treated with chemoradiation. However, artifacts result in inconsistent contouring at the time of brachytherapy. 3D Slicer is a free open source software application for medical image computing, and will be utilized for some aspects of research in MR Simulator Suite.

Tracking Information

NCT #
NCT04530019
Collaborators
Not Provided
Investigators
Study Chair: Akila Viswanathan, MD Johns Hopkins, School of Medicine, Radiation Oncology