MRI-Guided Brachytherapy in Treating Participants With HPV-Associated Stage IB2-IVA Cervical or Stage II-IVA Vaginal Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Phase 1 |
Detailed Description
PRIMARY OBJECTIVES:
- 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:
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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.
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Determine if diffusion weighted MRI findings are associated with immune infiltration as assessed by multi-spectral flow cytometry.
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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).
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment (MRI, internal radiation therapy) Participants undergo MRI scan during internal radiation therapy applicator placement. |
Radiation: Internal Radiation Therapy
Undergo brachytherapy
Other Names:
Procedure: Magnetic Resonance Imaging
Undergo MRI scan
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percent of patients achieving high-risk clinical target volume (HR-CTV) dose to 90% (D90) [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 Outcome Measures
- Diffusion weighted imaging (DWI) outcomes [Up to 4 years]
- Biomarker measurements (tumor viability and tumor T cell profile) from tumor samples [Up to 4 years]
A paired t-test will be used to compare apparent diffusion coefficient (ADC) areas for each biomarker.
- Disease recurrence (local, regional, and distant) [Up to 4 years]
determined via axial imaging (MRI or PET/CT) on interval follow-up
- Overall survival [Up to 4 years]
- Progression-free survival [Up to 4 years]
- Incidence and severity of treatment-related toxicities [Up to 4 years]
as defined via CTCAE v4.0
- Cost difference associated with the MRI-guided versus the standard process [Up to 4 years]
Billing and financial data will be calculated and compared to that of the conventional non-MRI-guided brachytherapy approach.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women with stage 1B2-IVA cervical cancer recommended to receive definitive chemoradiation including brachytherapy; or
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Women with stage II-IVA vaginal cancer recommended to receive definitive chemoradiation including brachytherapy.
Exclusion Criteria:
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Patient or tumor anatomy that requires use of a non-MRI-compatible applicator.
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Patients with implantable cardioverter-defibrillator, pacemaker or other implanted device or medical condition which precludes MRI acquisition.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Ann H Klopp, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2017-0823
- NCI-2018-01569
- 2017-0823
- P30CA016672