MRI Guided Brachytherapy for HPV-Associated Cervical and Vaginal Malignancies
Overview
- Phase
- Phase 1
- Intervention
- Magnetic Resonance Imaging
- Conditions
- Human Papillomavirus-Related Carcinoma
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Percent of patients achieving high-risk clinical target volume (HR-CTV) dose to 90% (D90)
- Status
- Active, not recruiting
- Last Updated
- 17 days ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women with stage 1B2-IVA cervical cancer recommended to receive definitive chemoradiation including brachytherapy; or
- •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.
Arms & Interventions
Treatment (MRI, internal radiation therapy)
Participants undergo MRI scan during internal radiation therapy applicator placement.
Intervention: Magnetic Resonance Imaging
Treatment (MRI, internal radiation therapy)
Participants undergo MRI scan during internal radiation therapy applicator placement.
Intervention: Internal Radiation Therapy
Outcomes
Primary Outcomes
Percent of patients achieving high-risk clinical target volume (HR-CTV) dose to 90% (D90)
Time Frame: Up to 4 years
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.
Secondary Outcomes
- Diffusion weighted imaging (DWI) outcomes(Up to 4 years)
- Progression-free survival(Up to 4 years)
- Biomarker measurements (tumor viability and tumor T cell profile) from tumor samples(Up to 4 years)
- Overall survival(Up to 4 years)
- Disease recurrence (local, regional, and distant)(Up to 4 years)
- Cost difference associated with the MRI-guided versus the standard process(Up to 4 years)
- Incidence and severity of treatment-related toxicities(Up to 4 years)