~4 spots leftby Dec 2025

Image-Guided Brachytherapy for Gynecologic Cancers

Recruiting in Palo Alto (17 mi)
+1 other location
AV
Overseen byAkila Viswanathan, M.D.
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Disqualifiers: Infection, Heart failure, Angina, others
No Placebo Group
Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Image-Guided Brachytherapy for Gynecologic Cancers?

Research shows that image-guided brachytherapy (IGBT) is considered the new gold standard for treating cervical cancer, with studies indicating it improves clinical outcomes, especially in patients with advanced stages of the disease.12345

Is image-guided brachytherapy (IGBT) safe for humans?

Research on image-guided brachytherapy (IGBT) for cervical cancer shows that it is generally safe, with studies reporting on its use and associated toxicity profiles. These studies focus on managing side effects and improving treatment delivery, indicating that safety is a key consideration in its application.15678

How is Image-Guided Brachytherapy different from other treatments for gynecologic cancers?

Image-Guided Brachytherapy (IGBT) is unique because it uses advanced imaging techniques like MRI and CT scans to precisely target cancerous tissues in gynecologic cancers, allowing for more accurate and effective radiation delivery compared to traditional methods. This approach can improve treatment outcomes and reduce damage to surrounding healthy tissues.148910

Research Team

AV

Akila Viswanathan, M.D.

Principal Investigator

Johns Hopkins Department of Radiation Oncology

Eligibility Criteria

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.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document.
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.
My cervical cancer is between Stage I and IVA, or I have a vaginal recurrence.
See 10 more

Exclusion 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.
Absolute neutrophil count < 500 at the time of enrollment

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo MRI-guided brachytherapy to treat gynecologic cancer

3 months
Multiple visits for brachytherapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years
Regular follow-up visits at 6 months, 1 year, and 2 years

Long-term follow-up

Participants are monitored for long-term outcomes such as survival and local failure rates

3 years

Treatment Details

Interventions

  • Image-Guided Brachytherapy (Brachytherapy)
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Image-Guided BrachytherapyExperimental Treatment1 Intervention
Magnetic Resonance Imaging (MRI) guided brachytherapy Procedure: Image-Guided Brachytherapy

Image-Guided Brachytherapy is already approved in Canada for the following indications:

🇨🇦
Approved in Canada as Image-Guided Brachytherapy for:
  • Cervical cancer
  • Endometrial cancer
  • Vaginal cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials
578
Recruited
33,600+
Dr. William G. Nelson profile image

Dr. William G. Nelson

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Director since 1992

MD, PhD

Dr. Elizabeth Jaffee profile image

Dr. Elizabeth Jaffee

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Chief Medical Officer since 2023

MD

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
Dr. Douglas R. Lowy profile image

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli profile image

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

In a study of 253 patients with advanced cervical squamous cell carcinoma, image-guided brachytherapy (IGBT) significantly reduced the rates of severe gastrointestinal and genitourinary complications compared to conventional two-dimensional brachytherapy (2DBT).
While overall and local relapse-free survival rates were similar between the two treatment methods, IGBT demonstrated a better therapeutic ratio by minimizing late toxicities, with gastrointestinal complications at 8.5% for IGBT versus 21.3% for 2DBT, and genitourinary complications at 1.7% for IGBT versus 11.8% for 2DBT.
Effectiveness of Image-guided Brachytherapy in Patients With Locally Advanced Cervical Squamous Cell Carcinoma Receiving Concurrent Chemoradiotherapy.Chen, SW., Liang, JA., Hung, YC., et al.[2019]
In a study of 128 patients with cervical cancer treated with MRI-guided brachytherapy, the 2-year local control rate was an impressive 91.6%, indicating high efficacy of this treatment approach.
The treatment showed low rates of severe side effects, with only 0.9% of patients experiencing grade 3 or greater gastrointestinal or genitourinary toxicity, suggesting that MRI-guided brachytherapy is a safe option for patients.
MRI-guided high-dose-rate intracavitary brachytherapy for treatment of cervical cancer: the University of Pittsburgh experience.Gill, BS., Kim, H., Houser, CJ., et al.[2022]

References

Clinical Outcomes of Computed Tomography-Based Volumetric Brachytherapy Planning for Cervical Cancer. [2016]
Implementation of image-guided brachytherapy for cervix cancer in the UK: progress update. [2016]
The promise of image-guided brachytherapy of better clinical outcomes in treatment of cervical cancer: Does it deliver? An Indian scenario. [2018]
Three-dimensional high dose rate intracavitary image-guided brachytherapy for the treatment of cervical cancer using a hybrid magnetic resonance imaging/computed tomography approach: feasibility and early results. [2022]
Improving dose delivery by adding interstitial catheters to fixed geometry applicators in high-dose-rate brachytherapy for cervical cancer. [2019]
Image guided brachytherapy in locally advanced cervical cancer: Improved pelvic control and survival in RetroEMBRACE, a multicenter cohort study. [2022]
Feasibility study of toxicity outcomes using GEC-ESTRO contouring guidelines on CT based instead of MRI-based planning in locally advanced cervical cancer patients. [2022]
Image-guided brachytherapy (IGBT) combined with whole pelvic intensity-modulated radiotherapy (WP-IMRT) for locally advanced cervical cancer: a prospective study from Chiang Mai University Hospital, Thailand. [2021]
Effectiveness of Image-guided Brachytherapy in Patients With Locally Advanced Cervical Squamous Cell Carcinoma Receiving Concurrent Chemoradiotherapy. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
MRI-guided high-dose-rate intracavitary brachytherapy for treatment of cervical cancer: the University of Pittsburgh experience. [2022]