Image-Guided Gynecologic Brachytherapy
Primary Purpose
Cervical Cancer, Uterine Cancer, Vaginal Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Image-Guided Brachytherapy
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer
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
Sites / Locations
- The SKCCC at Johns HopkinsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Image-Guided Brachytherapy
Arm Description
Magnetic Resonance Imaging (MRI) guided brachytherapy Procedure: Image-Guided Brachytherapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Time to local failure
To determine the local failure rates at 1 year and 2 year after MR Simulator Suite-guided placement.
Rate of survival
To determine the overall survival rates at 1 year and 2 year after MR Simulator Suite-guided placement.
Full Information
NCT ID
NCT02993900
First Posted
November 30, 2016
Last Updated
May 30, 2023
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02993900
Brief Title
Image-Guided Gynecologic Brachytherapy
Official Title
A Clinical Trial To Evaluate Image-Guided Gynecologic Brachytherapy In The MR Simulator Suite
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2016 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Uterine Cancer, Vaginal Cancer, Vulvar Cancer, Bladder Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Image-Guided Brachytherapy
Arm Type
Experimental
Arm Description
Magnetic Resonance Imaging (MRI) guided brachytherapy Procedure: Image-Guided Brachytherapy
Intervention Type
Device
Intervention Name(s)
Image-Guided Brachytherapy
Intervention Description
Brachytherapy will be precisely inserted with the assistance of magnetic resonance (MRI) scans
Primary Outcome Measure Information:
Title
Dosing changes
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
The rate of treatment-related toxicity
Description
To determine the rate of treatment-related toxicity within 3 months, 6 months and 1 year after MR Simulator Suite-guided placement.
Time Frame
3 months, 6 months and 1 year
Title
Time to local failure
Description
To determine the local failure rates at 1 year and 2 year after MR Simulator Suite-guided placement.
Time Frame
1 year and 2 year
Title
Rate of survival
Description
To determine the overall survival rates at 1 year and 2 year after MR Simulator Suite-guided placement.
Time Frame
1 year and 2 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shirley DiPasquale, R.N.
Phone
410-614-1598
Email
sdipasq1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akila Viswanathan, M.D.
Organizational Affiliation
Johns Hopkins Department of Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
The SKCCC at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirl DiPasquale, R.N.
Phone
410-614-1598
Email
sdipasq1@jhmi.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Image-Guided Gynecologic Brachytherapy
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