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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00098525 | Other Identifier | JHM IRB | |
| R21CA167800 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This research is being done to evaluate multimodality imaging, including magnetic resonance imaging-guided therapy (MRT), as a possible treatment for gynecologic cancers. The therapy takes place in the Department of Radiation Oncology at the Johns Hopkins SKCCC. The purpose of this study is to investigate the ability of MRI to successfully guide the placement of the brachytherapy applicator necessary to treat participants' gynecologic cancer. The Investigators want to see if the use of MRI will do a better job of assessing the tumor at the time of brachytherapy than the routinely used CT scan. The Investigators also want to determine if the use of MRI will enable doctors to reduce the radiation dose received by the body during the process of treating the tumor.
The goal of this trial is to assess how magnetic resonance imaging (MRI) may be used to improve tumor and normal tissue volume delineation, reducing toxicity and recurrence in gynecologic brachytherapy. The Investigators will compare dosimetric values to the organs at risk (OAR) with CT versus MRI planning. The Investigators anticipate that MR-planned cases will have lower OAR doses than standard CT-based cases due to more conformal planning. The Investigators will determine dose thresholds for radiation-related toxicity after treatment. The Investigators will compare toxicity rates at 6 months, 1 and 2 years after treatment, thereby enabling improved recommendations on dose limits to the OAR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Image-Guided Brachytherapy | Experimental | Magnetic Resonance Imaging (MRI) guided brachytherapy Procedure: Image-Guided Brachytherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Image-Guided Brachytherapy | Device | Brachytherapy will be precisely inserted with the assistance of magnetic resonance (MRI) scans |
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| Measure | Description | Time Frame |
|---|---|---|
| Dosing changes | To quantify the relative reduction of dose to rectum, sigmoid and bladder obtained after MR Simulator Suite-guided placement, as compared to standard CT guided treatment based on historical information and literature review. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of treatment-related toxicity | To determine the rate of treatment-related toxicity within 3 months, 6 months and 1 year after MR Simulator Suite-guided placement. | 3 months, 6 months and 1 year |
| Time to local failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shirley DiPasquale, R.N. | Contact | 410-614-1598 | sdipasq1@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Akila Viswanathan, M.D. | Johns Hopkins Department of Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The SKCCC at Johns Hopkins | Recruiting | Baltimore | Maryland | 21287 | United States |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D014594 | Uterine Neoplasms |
| D014625 | Vaginal Neoplasms |
| D014846 | Vulvar Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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To determine the local failure rates at 1 year and 2 year after MR Simulator Suite-guided placement.
| 1 year and 2 year |
| Rate of survival | To determine the overall survival rates at 1 year and 2 year after MR Simulator Suite-guided placement. | 1 year and 2 year |
| 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 |
| D014845 | Vulvar Diseases |
| D014571 | Urologic Neoplasms |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |