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

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


  • Org Study ID: J1660
  • Secondary ID: IRB00098525
  • NCT ID: NCT02993900
  • NCT Alias:
  • Sponsor: Sidney Kimmel Comprehensive Cancer Center - Other
  • Source: Sidney Kimmel Comprehensive Cancer Center

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. 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.

Overal Status Start Date Phase Study Type
Recruiting Start Date: September 2016 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Dosing changes

Primary Outcome 1 - Time Frame: 3 years

Condition:

  • Cervical Cancer
  • Uterine Cancer
  • Vaginal Cancer
  • Vulvar Cancer
  • Bladder Cancer

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
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Gender: Female

Minimum Age: 18 Years

Maximum Age: 100 Years

Healthy Volunteers: No

Official Information

Name: Akila Viswanathan, M.D.

Role: Principal Investigator

Affiliation: Johns Hopkins Department of Radiation Oncology

Overall Contact

Name: Shirley DiPasquale, R.N.

Phone: 410-614-1598

Email: sdipasq1@jhmi.edu

Location

Facility Status Contact
The SKCCC at Johns Hopkins
Baltimore, Maryland 21287
United States
Recruiting Shirl DiPasquale, R.N.
410-614-1598
sdipasq1@jhmi.edu