RECRUITING

Image-Guided Gynecologic Brachytherapy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2016-12-15
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02993900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Site/Stage
  3. * Any patient eligible for internal implantation without MR guidance will be considered eligible for this protocol. Standard criteria for internal implantation include:
  4. * Carcinoma of the cervix: Stage I-IVA or vaginal recurrence
  5. * Carcinoma of the uterus: Stage IIIB (vaginal involvement), inoperable, or vaginal recurrence
  6. * Carcinoma of the vagina: Stage I-IVA or vaginal recurrence
  7. * Carcinoma of the vulva: Stage I-IVA or recurrence
  8. * Carcinoma of the urethra based on treating physician's discretion
  9. * Patients who have received prior radiation or chemotherapy may be enrolled on this study.
  10. * Age \> 18 years. Children do not develop these malignancies and therefore are not considered candidates for this trial.
  11. * Life expectancy of greater than 6 months.
  12. * ECOG performance status of \<2 or greater, based on treating physician's discretion
  13. * MRI of the pelvis or PET-CT within 4 months before registration
  14. * Ability to understand and the willingness to sign a written informed consent document.
  1. * 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.
  2. * Absolute neutrophil count \< 500 at the time of enrollment
  3. * A history of metal in the head or eyes

Contacts and Locations

Study Contact

Shirley DiPasquale, R.N.
CONTACT
410-614-1598
sdipasq1@jhmi.edu

Principal Investigator

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

Study Locations (Sites)

The SKCCC at Johns Hopkins
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  • Akila Viswanathan, M.D., PRINCIPAL_INVESTIGATOR, Johns Hopkins Department of Radiation Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-12-15
Study Completion Date2028-12

Study Record Updates

Study Start Date2016-12-15
Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

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