Image-Guided Brachytherapy for Gynecologic Cancers

Recruiting at 1 trial location

Overseen By Shirley DiPasquale, R.N.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Disqualifiers: Infection, Heart failure, Angina, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 3 months

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating gynecologic cancers by using MRI, a detailed imaging technique, to guide brachytherapy, a type of internal radiation therapy. The researchers aim to determine if MRI can more accurately place the brachytherapy device and reduce radiation exposure compared to the usual CT scan method. Participants must have a confirmed diagnosis of specific gynecologic cancers, such as cervical or uterine cancer, and be eligible for internal radiation treatment. As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could enhance future cancer treatments.

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 prior data suggests that this method is safe for gynecologic cancer treatment?

Research has shown that MRI-guided brachytherapy is generally manageable for patients. Studies have found that this method, used to treat cervical cancer, can improve treatment outcomes without increasing side effects. Some patients have reported common radiation side effects, such as fatigue or skin irritation, but these are usually mild. Overall, MRI guidance helps doctors target the treatment more accurately at the cancer, potentially reducing radiation exposure to healthy tissues. Previous research suggests that the treatment is safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about image-guided brachytherapy for gynecologic cancers because it uses MRI to precisely deliver radiation, which is more accurate than traditional methods. Standard treatments like external beam radiation therapy often affect surrounding healthy tissues, but this technique targets the tumor directly, potentially reducing side effects and improving outcomes. The precision of MRI guidance allows for customized treatment plans tailored to the unique anatomy of each patient, which could lead to more effective and personalized cancer care.

What evidence suggests that this image-guided brachytherapy is effective for gynecologic cancers?

Research has shown that image-guided brachytherapy, particularly with MRI, holds promise for treating gynecologic cancers such as cervical cancer. Studies indicate that MRI-guided brachytherapy enables doctors to target tumors with greater precision, leading to improved outcomes. Specifically, patients treated with this method have demonstrated better survival rates compared to those who received traditional brachytherapy. MRI provides clearer images of the tumor, aiding doctors in placing the treatment applicator more accurately. Additionally, this approach can reduce radiation exposure to healthy tissues, potentially lowering side effects. Overall, these findings suggest that MRI-guided brachytherapy could be an effective option for treating certain gynecologic cancers. ^{3 5 6 7 8}

Who Is on the Research Team?

Akila Viswanathan, M.D.

Principal Investigator

Johns Hopkins Department of Radiation Oncology

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Image-Guided Brachytherapy

Trial Overview

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.

How Is the Trial Designed?

Group I: Image-Guided Brachytherapy Experimental Treatment 1 Intervention

Magnetic Resonance Imaging (MRI) guided brachytherapy Procedure: Image-Guided Brachytherapy

Image-Guided Brachytherapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Image-Guided Brachytherapy for:

• Cervical cancer
• Endometrial cancer
• Vaginal cancer

Approved in United States as Image-Guided Brachytherapy for:

• Cervical cancer
• Endometrial cancer
• Vaginal cancer

Approved in Canada as Image-Guided Brachytherapy for:

• Cervical cancer
• Endometrial cancer
• Vaginal cancer

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 76 women with cervical cancer, the CT-based image-guided brachytherapy (IGBT) technique showed promising results with a 2-year overall survival rate of 75% and a local failure rate of only 5.8%, indicating effective treatment outcomes.

The treatment was associated with manageable toxicity, as 38% of patients experienced grade ≥ 2 acute toxicity, but there were no severe late complications (grade ≥ 3), suggesting that IGBT is a safe option for cervical cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Computed Tomography-Based Volumetric Brachytherapy Planning for Cervical Cancer. Simpson, DR., Scanderbeg, DJ., Carmona, R., et al.[2016]

In a study of 44 cervical cancer patients, image-guided brachytherapy (IGBT) using a combination of MRI and CT planning resulted in a high mean dose to the high-risk clinical target volume (HRCTV) of 83.3 Gy, leading to a remarkable 97.7% complete response rate after treatment.

The two-year survival rates were promising, with 88% local control, 85% disease-specific survival, and 86% overall survival, indicating that this hybrid imaging approach is effective for treating cervical cancer, although further research is needed for long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Beriwal, S., Kannan, N., Kim, H., et al.[2022]

In a study of 731 patients with locally advanced cervical cancer, image-guided brachytherapy (IGBT) combined with chemotherapy and external beam radiation therapy (EBRT) resulted in high local control rates of 91% at 3 years and 89% at 5 years, indicating its efficacy in treating this condition.

The treatment was associated with low rates of severe morbidity, with only 5-7% of patients experiencing grade 3-5 complications in bladder, gastrointestinal tract, and vaginal areas, suggesting that IGBT is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image guided brachytherapy in locally advanced cervical cancer: Improved pelvic control and survival in RetroEMBRACE, a multicenter cohort study. Sturdza, A., Pötter, R., Fokdal, LU., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

MRI-based image-guided brachytherapy (IGBT) showed high effectiveness in treating locally advanced cervical cancer, achieving 88.7% local control and 94% overall survival at two years in a study of 151 patients.

The treatment resulted in limited severe long-term side effects, with only 3.8% of patients experiencing grade 3-4 bladder and bowel toxicities, indicating a favorable safety profile for this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The promise of image-guided brachytherapy of better clinical outcomes in treatment of cervical cancer: Does it deliver? An Indian scenario. Tiwari, R., Narayanan, GS., Jayakumar, V., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 42 patients with locally advanced cervical cancer, the use of interstitial (IS) catheters in image-guided brachytherapy (IGBT) significantly increased the dose delivered to the high-risk clinical target volume (CTVHR) by an average of 5.8 Gy without raising the dose to surrounding organs at risk like the bladder and bowel.

Seventy-four percent of the patients treated with IGBT had IS catheters, and those with IS catheters were more likely to have larger tumor volumes, indicating that IS catheters are particularly beneficial for treating bulkier tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving dose delivery by adding interstitial catheters to fixed geometry applicators in high-dose-rate brachytherapy for cervical cancer. Otter, S., Coates, A., Franklin, A., et al.[2019]

The implementation of image-guided brachytherapy (IGBT) for cervix cancer in the UK has significantly increased, with 71% of centers using CT or MRI-based techniques in 2011, up from 26% in 2008.

The use of tandem-ring applicators has also risen, indicating a shift in treatment approaches, while the majority of centers continue to prescribe doses of 70Gy(10) or higher to point A, reflecting adherence to effective treatment standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of image-guided brachytherapy for cervix cancer in the UK: progress update. Tan, LT.[2016]

In a study involving 15 patients with locally advanced cervical cancer, the combination of image-guided brachytherapy (IGBT) and whole pelvic intensity-modulated radiation therapy (WP-IMRT) resulted in excellent local control rates of 93% and no severe toxicities (grade 3-4) observed during treatment.

The use of IGBT improved the radiation dose distribution, significantly reducing exposure to surrounding organs at risk (OARs) like the bladder and rectum, which suggests a safer treatment approach while maintaining effective tumor control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Tharavichitkul, E., Wanwilairat, S., Chakrabandhu, S., et al.[2021]

In a study of 95 women with cervical cancer treated with a combination of chemotherapy and CT-based image-guided brachytherapy, significant late rectal and bladder toxicities were observed, with 23% experiencing grade 2 proctitis and 11% grade 3 proctitis.

Despite the use of CT-based planning, the toxicity rates were higher than those reported in MRI-based planning studies, suggesting that integrating MRI-guided techniques or intensity-modulated radiation therapy could potentially reduce these adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility study of toxicity outcomes using GEC-ESTRO contouring guidelines on CT based instead of MRI-based planning in locally advanced cervical cancer patients. Koh, V., Choo, BA., Lee, KM., et al.[2022]

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