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

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. ^{1 2 3 4 5}

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. ^{1 5 6 7 8}

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. ^{1 4 8 9 10}

Research Team

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.

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

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

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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 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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Computed Tomography-Based Volumetric Brachytherapy Planning for Cervical Cancer. [2016]

2. England pubmed.ncbi.nlm.nih.gov

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

3. United States 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. [2018]

4. England 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Improving dose delivery by adding interstitial catheters to fixed geometry applicators in high-dose-rate brachytherapy for cervical cancer. [2019]

6. Ireland pubmed.ncbi.nlm.nih.gov

Image guided brachytherapy in locally advanced cervical cancer: Improved pelvic control and survival in RetroEMBRACE, a multicenter cohort study. [2022]

7. United States 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. [2022]

8. Poland 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. [2021]

9. Greece pubmed.ncbi.nlm.nih.gov

Effectiveness of Image-guided Brachytherapy in Patients With Locally Advanced Cervical Squamous Cell Carcinoma Receiving Concurrent Chemoradiotherapy. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

MRI-guided high-dose-rate intracavitary brachytherapy for treatment of cervical cancer: the University of Pittsburgh experience. [2022]