| NCT ID | NCT02993900 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2016-12-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2016-12-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Akila Viswanathan, M.D.
PRINCIPAL INVESTIGATOR
Johns Hopkins Department of Radiation Oncology
Frequently Asked Questions
Who can join the NCT02993900 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 100 Years, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02993900 currently recruiting?
Yes, NCT02993900 is actively recruiting participants. Contact the research team at sdipasq1@jhmi.edu for enrollment information.
Where is the NCT02993900 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT02993900 clinical trial?
NCT02993900 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The principal investigator is Akila Viswanathan, M.D. at Johns Hopkins Department of Radiation Oncology. The trial plans to enroll 54 participants.
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