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Brachytherapy
Image-Guided Brachytherapy for Gynecologic Cancers
N/A
Recruiting
Led By Akila Viswanathan, M.D.
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Carcinoma of the cervix: Stage I-IVA or vaginal recurrence
Carcinoma of the uterus: Stage IIIB (vaginal involvement), inoperable, or vaginal recurrence
Must not have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year and 2 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether magnetic resonance imaging-guided therapy (MRT) is a better treatment for gynecologic cancers than the routinely used CT scan.
Who is the study for?
This trial is for adults over 18 with various gynecologic cancers (vulvar, vaginal, bladder, uterine, cervical) who are eligible for internal radiation therapy. They must have a life expectancy of more than 6 months and be physically able to participate (ECOG <2). Prior treatments like radiation or chemotherapy are allowed. Exclusions include severe illnesses that could affect study participation or having metal in the head/eyes.
What is being tested?
The trial tests if MRI can guide brachytherapy applicator placement better than CT scans for treating gynecologic cancers. It aims to see if MRI improves tumor assessment during treatment and helps reduce unnecessary radiation exposure to the body.
What are the potential side effects?
While specific side effects aren't listed here, brachytherapy generally may cause localized pain, swelling or bruising at the treatment site, fatigue from radiation exposure and potential short-term changes in urinary or bowel habits.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cervical cancer is between Stage I and IVA, or I have a vaginal recurrence.
Select...
My uterine cancer is at stage IIIB, inoperable, or has recurred in the vagina.
Select...
My cancer is in the vagina and is between stages I-IVA or has come back.
Select...
I am older than 18 years.
Select...
My vulvar cancer is between Stage I and IVA or has come back.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any serious illnesses that would stop me from following the study's requirements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year and 2 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year and 2 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dosing changes
Secondary study objectives
Rate of survival
The rate of treatment-related toxicity
Time to local failure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Image-Guided BrachytherapyExperimental Treatment1 Intervention
Magnetic Resonance Imaging (MRI) guided brachytherapy Procedure: Image-Guided Brachytherapy
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Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
570 Previous Clinical Trials
33,176 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,927 Previous Clinical Trials
41,017,951 Total Patients Enrolled
Akila Viswanathan, M.D.Principal InvestigatorJohns Hopkins Department of Radiation Oncology
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious illnesses that would stop me from following the study's requirements.You have had metal objects in your head or eyes in the past.My cervical cancer is between Stage I and IVA, or I have a vaginal recurrence.My uterine cancer is at stage IIIB, inoperable, or has recurred in the vagina.My cancer is in the vagina and is between stages I-IVA or has come back.My doctor diagnosed me with urethra cancer.I am older than 18 years.My doctor believes I can perform daily activities with little or no help.I am eligible for an internal implant without needing MR guidance.I have had an MRI of the pelvis or PET-CT within the last 4 months.I have had chemotherapy or radiation before.My vulvar cancer is between Stage I and IVA or has come back.
Research Study Groups:
This trial has the following groups:- Group 1: Image-Guided Brachytherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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