MRI-Guided Brachytherapy for Gynecologic Cancer

Overseen By Martin King, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Uncontrolled illness, MRI contraindications, 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: Unknown

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how magnetic resonance imaging (MRI) can enhance the effectiveness of brachytherapy for gynecologic cancers. Researchers are testing two approaches: using an MRI tracker to guide the treatment and proceeding without the tracker. The goal is to determine if these new MRI tools can improve the targeting of cancer cells. This trial suits women diagnosed with primary or recurrent gynecologic cancer, such as cervical or ovarian cancer, who plan to receive brachytherapy as part of their standard treatment. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance treatment precision for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether 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 MRI-guided brachytherapy is safe for gynecologic cancer?

Research shows that MRI-guided brachytherapy has gained popularity over the last 20 years. Studies indicate that patients generally tolerate this treatment well. Specifically, research on MRI-guided brachytherapy for cervical cancer has demonstrated its safety and effectiveness. This treatment involves placing a small radioactive source near the cancer, with MRI aiding in accurately targeting the tumor.

Although specific side effects are not detailed in the sources, the treatment's widespread use and growing popularity suggest it is considered safe for clinical use. No major issues have been reported, indicating that severe side effects are uncommon. Participants can expect a procedure carefully monitored and guided by MRI to ensure precise treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MRI-guided brachytherapy for gynecologic cancer because it offers more precise treatment delivery compared to traditional methods. Traditional brachytherapy often relies on CT imaging, but MRI provides clearer images of soft tissues, allowing for more accurate catheter placement and dose distribution. This technique, especially with the use of an MRI tracker, enhances the precision in targeting cancerous tissues while sparing healthy ones, potentially leading to fewer side effects and improved outcomes for patients.

What evidence suggests that MRI-guided brachytherapy is effective for gynecologic cancer?

This trial will compare two approaches to MRI-guided brachytherapy for treating gynecologic cancers, such as cervical cancer. Studies have shown that MRI-guided brachytherapy effectively helps doctors see tumors more clearly and target them better during treatment, leading to improved outcomes. Research indicates that using MRI during brachytherapy can shrink tumors and increase survival rates. In one arm of this trial, trackers allow for even more precise placement of the treatment, potentially enhancing results further. MRI guidance is safe, with minimal serious side effects, and has been linked to excellent clinical outcomes. Overall, MRI-guided brachytherapy shows promise for improving the treatment of gynecologic cancers. ^{1 6 7 8 9}

Who Is on the Research Team?

Martin T. King, MD, PhD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with gynecologic cancers (like cancer of the endometrium, ovaries, cervix, vagina, or vulva) who are suitable and choose to undergo MRI-guided brachytherapy. They must understand the study and agree to follow its procedures. Prior radiation or chemotherapy is okay. However, those with certain medical implants that aren't safe in an MRI machine or have serious illnesses affecting their ability to participate are excluded.

Inclusion Criteria

I am willing and able to follow the study's requirements, including treatments and visits.

I have a confirmed gynecologic cancer and am planning to undergo brachytherapy.

I can take care of myself but cannot do heavy physical work.

Exclusion Criteria

Contraindication to MRI identified by the MR procedure screening form, such as a pacemaker, aneurysm clip, inner ear implant, neurostimulator, or other non-MR compatible implant or device

I do not have any serious ongoing illnesses that my doctor is still trying to control.

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 with or without the use of an MR-tracker for catheter positioning and treatment planning

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including local-failure-free survival and overall survival

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Brachytherapy

Trial Overview The study aims to improve brachytherapy for gynecologic cancer using new tools developed with magnetic resonance imaging (MRI). Participants will receive this advanced form of treatment which allows precise targeting of cancerous tissue while sparing healthy areas.

How Is the Trial Designed?

Group I: MRI Guided BRACHYTHERAPY without Tracker Experimental Treatment 2 Interventions

* Standard pelvic MRI sequences will be obtained * Standard process is used with serial MR imaging to evaluate catheter position during implant * All patients will undergo 3D-based image acquisition for brachytherapy treatment planning per standard clinical practice * The brachytherapy modality to be used is high-dose-rate brachytherapy using an iridum-192 stepping source

Group II: MRI Guided BRACHYTHERAPY with Tracker Experimental Treatment 3 Interventions

* Standard pelvic MRI sequences will be obtained * MRI Tracker is used during catheter positioning with serial MR imaging during implant * All patients will undergo 3D-based image acquisition for brachytherapy treatment planning per standard clinical practice * The brachytherapy modality to be used is high-dose-rate brachytherapy using an iridum-192 stepping source

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

Approved in United States as Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Breast cancer
• Skin cancer
• Esophageal cancer

Approved in European Union as Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Breast cancer
• Skin cancer
• Esophageal cancer
• Brain tumors

Approved in Canada as Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Breast cancer
• Skin cancer
• Esophageal cancer

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Kaye Foundation, Brigham and Women's Hospital

Collaborator

Trials

1

Recruited

50+

Friends of Dana-Farber, Dana-Farber Cancer Institute

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

In a study of 126 cervical cancer patients, 3D MRI-guided brachytherapy (IGBT) showed a trend towards improved local control and overall survival compared to 2D conventional brachytherapy (CBT), with local control rates of 93% after 1 year and 88% after 3 years.

The use of interstitial needles in IGBT allowed for higher doses to the high-risk clinical target volume while reducing radiation exposure to the bladder, resulting in decreased toxicity from 17% in the 2D cohort to 12% in the 3D cohort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of brachytherapy technique (2D versus 3D) on outcome following radiotherapy of cervical cancer. Derks, K., Steenhuijsen, JLG., van den Berg, HA., 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4663219/

Magnetic resonance imaging-guided brachytherapy for ... Clinical outcome and dosimetric parameters of chemo-radiation including MRI guided adaptive brachytherapy with tandem-ovoid applicators for cervical cancer ...

2. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.841980/full

Clinical Outcomes of MRI-Guided Adaptive Brachytherapy ... This study aims to evaluate clinical outcomes of MRI-guided adaptive brachytherapy (MR-IGABT) for each brachytherapy fraction in patients with locally advanced ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1538472125001229

Iterative intraoperative 3T MRI (iMRI)-guided ... iMRI-guidance for gynecologic brachytherapy is safe, associated with minimal high-grade toxicity and excellent clinical outcomes. Future studies ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4147854/

MRI-guided brachytherapy - PMC - PubMed Central The application of MRI-guided brachytherapy has demonstrated significant growth during the last two decades. Clinical improvements in cervix cancer outcomes ...

5. withpower.com withpower.com/trial/phase-uterine-neoplasms-11-2016-0d70a

Image-Guided Brachytherapy for Gynecologic Cancers 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 ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1053429614000241

Magnetic Resonance Image Guided Brachytherapy The application of magnetic resonance image (MRI)–guided brachytherapy has demonstrated significant growth during the past 2 decades.

7. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2024.1442712/full

Brachytherapy for cervical cancer: from intracavitary to ... In this paper, the research progress of three-dimensional (3D) brachytherapy for cervical cancer in recent years is reviewed.

8. mdpi.com mdpi.com/2072-6694/17/5/770

MRI-Guided Multi-Catheter High-Dose-Rate Interstitial ... The purpose of the present study was to evaluate the efficacy and toxicity of MRI-guided ISBT for locally advanced cervical cancer that is unsuitable for ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6304405/

Efficacy and dosimetry analysis of image-guided radioactive ... They concluded that permanent interstitial implantation with radioactive 198Au seeds was a feasible strategy for patients with recurrent gynecologic tumor, with ...