Image-Guided Gynecologic Brachytherapy
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|ClinicalTrials.gov Identifier: NCT02993900|
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : December 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Uterine Cancer Vaginal Cancer Vulvar Cancer Bladder Cancer||Device: Image-Guided Brachytherapy||Phase 2|
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. To analyze the correlation of T2 and diffusion weighted MR-imaging characteristics with pathologically determined markers of proliferation, the Investigators will biopsy tissue at the time of 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Trial To Evaluate Image-Guided Gynecologic Brachytherapy In The MR Simulator Suite|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
Experimental: Image-Guided Brachytherapy
Magnetic Resonance Imaging (MRI) guided brachytherapy Procedure: Image-Guided Brachytherapy
Device: Image-Guided Brachytherapy
Brachytherapy will be precisely inserted with the assistance of magnetic resonance (MRI) scans
- Dosing changes [ Time Frame: 3 years ]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.
- The rate of treatment-related toxicity [ Time Frame: 3 months, 6 months and 1 year ]To determine the rate of treatment-related toxicity within 3 months, 6 months and 1 year after MR Simulator Suite-guided placement.
- Time to local failure [ Time Frame: 1 year and 2 year ]To determine the local failure rates at 1 year and 2 year after MR Simulator Suite-guided placement.
- Rate of survival [ Time Frame: 1 year and 2 year ]To determine the overall survival rates at 1 year and 2 year after MR Simulator Suite-guided placement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993900
|Contact: Shirley DiPasquale, R.N.||email@example.com|
|United States, Maryland|
|The SKCCC at Johns Hopkins||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Shirl DiPasquale, R.N. 410-614-1598 firstname.lastname@example.org|
|Principal Investigator:||Akila Viswanathan, M.D.||Johns Hopkins Department of Radiation Oncology|