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

49 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim of this study is to develop new tools using magnetic resonance imaging (MRI) that will improve the brachytherapy procedure and treatment for participants with gynecologic cancer.

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 data supports the effectiveness of the treatment MRI-Guided Brachytherapy for Gynecologic Cancer?

Research shows that MRI-guided brachytherapy, which uses imaging to precisely place radioactive sources inside tumors, is effective for treating cervical cancer. Studies indicate that this method improves tumor visibility and treatment planning, leading to better outcomes compared to older techniques. ^{1 2 3 4 5}

Is MRI-guided brachytherapy safe for humans?

Research on MRI-guided brachytherapy for cervical cancer shows it is generally safe, with studies focusing on analyzing toxicities and optimizing treatment planning to minimize risks. ^{1 6 7 8 9}

How is MRI-guided brachytherapy different from other treatments for gynecologic cancer?

MRI-guided brachytherapy is unique because it uses magnetic resonance imaging (MRI) to precisely place radioactive sources inside the tumor, allowing for better targeting of the cancer while minimizing damage to surrounding healthy tissue. This approach improves the accuracy of treatment and can lead to better outcomes compared to traditional methods that do not use MRI guidance. ^{1 2 10 11 12}

Research Team

Martin T. King, MD, PhD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. 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]

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

Magnetic Resonance-Guided Gynecologic Brachytherapy. [2015]

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

The Vienna applicator for combined intracavitary and interstitial brachytherapy of cervical cancer: design, application, treatment planning, and dosimetric results. [2022]

4. Poland pubmed.ncbi.nlm.nih.gov

Impact of brachytherapy technique (2D versus 3D) on outcome following radiotherapy of cervical cancer. [2022]

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

Interventional Radiation Oncology (IRO): Transition of a magnetic resonance simulator to a brachytherapy suite. [2019]

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

Toxicities and dose-volume histogram parameters of MRI-based brachytherapy for cervical cancer. [2018]

7. Ireland pubmed.ncbi.nlm.nih.gov

MRI-based low dose-rate brachytherapy experience in locally advanced cervical cancer patients initially treated by concomitant chemoradiotherapy. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

MRI-guided treatment-planning optimisation in intracavitary or combined intracavitary/interstitial PDR brachytherapy using tandem ovoid applicators in locally advanced cervical cancer. [2022]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety and efficacy of 3D-printed templates assisted CT-guided radioactive iodine-125 seed implantation for the treatment of recurrent cervical carcinoma after external beam radiotherapy. [2021]

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

Evaluation of an active magnetic resonance tracking system for interstitial brachytherapy. [2019]

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

Open magnetic resonance imaging using titanium-zirconium needles: improved accuracy for interstitial brachytherapy implants? [2019]

12. Netherlands pubmed.ncbi.nlm.nih.gov

3-T MR-guided brachytherapy for gynecologic malignancies. [2021]