Image-Guided Gynecologic Brachytherapy

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02993900
• Other study ID #: J1660
• Secondary ID: IRB00098525R21CA
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2016
• Est. completion date: December 2028

Study information

• Verified date: May 2023
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: Shirley DiPasquale, R.N.
• Phone: 410-614-1598
• Email: sdipasq1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 2028
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Image-Guided Brachytherapy
Brachytherapy will be precisely inserted with the assistance of magnetic resonance (MRI) scans

Locations

Country	Name	City	State
United States	The SKCCC at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosing changes	To quantify the relative reduction of dose to rectum, sigmoid and bladder obtained after MR Simulator Suite-guided placement, as compared to standard CT guided treatment based on historical information and literature review.	3 years
Secondary	The rate of treatment-related toxicity	To determine the rate of treatment-related toxicity within 3 months, 6 months and 1 year after MR Simulator Suite-guided placement.	3 months, 6 months and 1 year
Secondary	Time to local failure	To determine the local failure rates at 1 year and 2 year after MR Simulator Suite-guided placement.	1 year and 2 year
Secondary	Rate of survival	To determine the overall survival rates at 1 year and 2 year after MR Simulator Suite-guided placement.	1 year and 2 year