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. 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 | December 15, 2016 | N/A | Interventional |
Primary Outcome 1 - Measure: Dosing changes
Primary Outcome 1 - Time Frame: 3 years
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
Name: Akila Viswanathan, M.D.
Role: Principal Investigator
Affiliation: Johns Hopkins Department of Radiation Oncology
Name: Shirley DiPasquale, R.N.
Phone: 410-614-1598
Email: sdipasq1@jhmi.edu
| Facility | Status | Contact |
|---|---|---|
| The SKCCC at Johns Hopkins Baltimore, Maryland 21287 United States |
Recruiting |
Shirl DiPasquale, R.N. 410-614-1598 sdipasq1@jhmi.edu |
