Houston, Texas 77030


Purpose:

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.


Study summary:

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 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.


Criteria:

Inclusion Criteria: - Women with stage 1B2-IVA cervical cancer recommended to receive definitive chemoradiation including brachytherapy. - Women with stage II-IVA vaginal cancer recommended to receive definitive chemoradiation including brachytherapy. Exclusion Criteria: - Patient or tumor anatomy that requires use of a non-MRI-compatible applicator. - Patients with implantable cardioverter-defibrillator, pacemaker or other implanted device or medical condition which precludes MRI acquisition.


NCT ID:

NCT03634267


Primary Contact:

Principal Investigator
Ann Klopp
M.D. Anderson Cancer Center

Ann Klopp
Phone: 713-563-2300
Email: aklopp@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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