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Image-Guided Gynecologic Brachytherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02993900
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : August 9, 2019
National Cancer Institute (NCI)
Maryland Cigarette Restitution Fund
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Uterine Cancer Vaginal Cancer Vulvar Cancer Bladder Cancer Device: Image-Guided Brachytherapy Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial To Evaluate Image-Guided Gynecologic Brachytherapy In The MR Simulator Suite
Actual Study Start Date : February 27, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Participants must have histologically or cytologically confirmed carcinoma. Central pathology review is not required; however, pathology will be reviewed at the SKCCC at Johns Hopkins.
  • Site/Stage
  • Any patient eligible for internal implantation without MR guidance will be considered eligible for this protocol. Standard criteria for internal implantation include:
  • Carcinoma of the cervix: Stage I-IVA or vaginal recurrence
  • Carcinoma of the uterus: Stage IIIB (vaginal involvement), inoperable, or vaginal recurrence
  • Carcinoma of the vagina: Stage I-IVA or vaginal recurrence
  • Carcinoma of the vulva: Stage I-IVA or recurrence
  • Carcinoma of the urethra based on treating physician's discretion
  • Patients who have received prior radiation or chemotherapy may be enrolled on this study.
  • Age > 18 years. Children do not develop these malignancies and therefore are not considered candidates for this trial.
  • Life expectancy of greater than 6 months.
  • ECOG performance status of <2 or greater, based on treating physician's discretion
  • MRI of the pelvis or PET-CT within 4 months before registration
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Absolute neutrophil count < 500 at the time of enrollment
  • A history of metal in the head or eyes

Information from the National Library of Medicine

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 identifier (NCT number): NCT02993900

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Contact: Shirley DiPasquale, R.N. 410-614-1598

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United States, Maryland
The SKCCC at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Shirl DiPasquale, R.N.    410-614-1598   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
Maryland Cigarette Restitution Fund
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Principal Investigator: Akila Viswanathan, M.D. Johns Hopkins Department of Radiation Oncology

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Identifier: NCT02993900    
Other Study ID Numbers: J1660
IRB00098525 ( Other Identifier: JHM IRB )
5R21CA167800-02 ( U.S. NIH Grant/Contract )
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Vulvar Neoplasms
Vaginal Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Vulvar Diseases
Vaginal Diseases