Image-Guided Gynecologic Brachytherapy

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Brief Title

Image-Guided Gynecologic Brachytherapy

Official Title

A Clinical Trial To Evaluate Image-Guided Gynecologic Brachytherapy In The MR Simulator Suite

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.
    

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. 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


Primary Outcome

Dosing changes

Secondary Outcome

 The rate of treatment-related toxicity

Condition

Cervical Cancer

Intervention

Image-Guided Brachytherapy

Study Arms / Comparison Groups

 Image-Guided Brachytherapy
Description:  Magnetic Resonance Imaging (MRI) guided brachytherapy Procedure: Image-Guided Brachytherapy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

54

Start Date

December 15, 2016

Completion Date

December 2024

Primary Completion Date

December 2021

Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Akila Viswanathan, M.D., 410-614-1598, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02993900

Organization ID

J1660

Secondary IDs

IRB00098525

Responsible Party

Sponsor

Study Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Akila Viswanathan, M.D., Principal Investigator, Johns Hopkins Department of Radiation Oncology


Verification Date

April 2021