Image-Guided Gynecologic Brachytherapy

Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Dec 14, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat certain types of gynecologic cancers, including cervical, uterine, vaginal, vulvar, and bladder cancers, using advanced imaging technology. Researchers at Johns Hopkins are examining whether using MRI (a type of imaging that creates detailed pictures of the inside of the body) can help doctors place a device called a brachytherapy applicator more accurately than the traditional CT scan. The goal is to see if MRI can not only help doctors better understand the tumor but also allow them to reduce the amount of radiation that the rest of the body receives during treatment.

To participate in this trial, women aged 18 and older who have been diagnosed with specific stages of these cancers may be eligible, even if they have previously received radiation or chemotherapy. Participants should be in good enough health to tolerate the study and must be able to understand and sign a consent form. If you decide to join, you can expect to receive personalized treatment guided by MRI, and you’ll be contributing to important research that may improve cancer treatment for others in the future.

Gender

FEMALE

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