This trial studies how well magnetic resonance imaging (MRI)-guided internal radiation therapy (brachytherapy) works in treating participants with human papillomavirus (HPV) associated stage IB2-IV cervical or stage II-IVA vaginal cancer. Using MRI guidance during brachytherapy applicator placement may improve treatment planning in participants with cervical or vaginal cancer.
PRIMARY OBJECTIVES: I. Determine whether MRI guidance during internal radiation therapy applicator placement improves the high-risk clinical target volume (HR-CTV) D90 (dose to 90% of the high-risk clinical target volume) rate compared to conventional guidance, with ultrasound and freehand technique, for patients with cervical and vaginal cancer. SECONDARY OBJECTIVES: I. Identify diffusion weighted MRI image features that can be used to identify sites of viable tumor following external beam radiotherapy as assessed by tumor aspirate cytology. II. Determine if diffusion weighted MRI findings are associated with immune infiltration as assessed by multi-spectral flow cytometry. III. Identify potential correlates between clinical outcomes (survival, progression) and these data objectives (brachytherapy dosimetry/therapeutic ratio, diffusion-weighted MRI imaging features, tumor aspirate cytology findings). IV. Define the financial costs and feasibility of an MRI-guided brachytherapy approach to determine the overall healthcare quality value (outcomes/cost) of this novel approach for application at other brachytherapy centers. OUTLINE: Participants undergo MRI scan during internal radiation therapy applicator placement.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Undergo brachytherapy
Undergo MRI scan
M D Anderson Cancer Center
Houston, Texas, United States
Percent of patients achieving high-risk clinical target volume (HR-CTV) dose to 90% (D90)
Rate will be compared to conventional guidance, with ultrasound and freehand technique. We will compare the HR-CTV D90 and other secondary dosimetry parameters (e.g. D2 cc bladder, D2 cc rectum etc.) between the initial scan (subsequent to ultrasound \[US\] guided or freehand applicator placement) and optimized (with magnetic resonance imaging \[MRI\] guided placement) treatment plan for each patient using McNemar's test.
Time frame: Up to 4 years
Diffusion weighted imaging (DWI) outcomes
Time frame: Up to 4 years
Biomarker measurements (tumor viability and tumor T cell profile) from tumor samples
A paired t-test will be used to compare apparent diffusion coefficient (ADC) areas for each biomarker.
Time frame: Up to 4 years
Disease recurrence (local, regional, and distant)
determined via axial imaging (MRI or PET/CT) on interval follow-up
Time frame: Up to 4 years
Overall survival
Time frame: Up to 4 years
Progression-free survival
Time frame: Up to 4 years
Incidence and severity of treatment-related toxicities
as defined via CTCAE v4.0
Time frame: Up to 4 years
Cost difference associated with the MRI-guided versus the standard process
Billing and financial data will be calculated and compared to that of the conventional non-MRI-guided brachytherapy approach.
Time frame: Up to 4 years
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