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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01569 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2017-0823 | Other Identifier | M D Anderson Cancer Center | |
| P30CA016672 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (MRI, internal radiation therapy) | Experimental | Participants undergo MRI scan during internal radiation therapy applicator placement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internal Radiation Therapy | Radiation | Undergo brachytherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Diffusion weighted imaging (DWI) outcomes | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann H Klopp | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Magnetic Resonance Imaging | Procedure | Undergo MRI scan |
|
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| Up to 4 years |
| Disease recurrence (local, regional, and distant) | determined via axial imaging (MRI or PET/CT) on interval follow-up | Up to 4 years |
| Overall survival | Up to 4 years |
| Progression-free survival | Up to 4 years |
| Incidence and severity of treatment-related toxicities | as defined via CTCAE v4.0 | 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. | Up to 4 years |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D014625 | Vaginal Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014623 | Vaginal Diseases |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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