MRI-Guided Internal Radiation for Cervical and Vaginal Cancer

Overseen By Ann Klopp

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Implanted devices, Non-MRI-compatible anatomy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 4 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether MRI-guided brachytherapy can improve treatment for cervical and vaginal cancer linked to HPV. The focus is on stage IB2-IV cervical cancer and stage II-IVA vaginal cancer. Participants undergo MRI scans during internal radiation to help doctors plan treatment more effectively. Women advised to receive chemoradiation, including internal radiation, for these specific cancer stages may be suitable for this trial. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.

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

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 internal radiation therapy is safe for treating cervical and vaginal cancer?

Research has shown that MRI-guided internal radiation therapy, or brachytherapy, holds promise for treating cervical and vaginal cancers. Using MRI during this treatment helps doctors target the tumor more accurately, reducing the risk of exposing healthy tissues to unnecessary radiation.

Previous studies suggest that MRI-guided brachytherapy is generally well-tolerated and has been linked to better outcomes in cervical cancer treatment. Although this therapy is still under investigation, serious side effects are uncommon in the available data. Patients often experience mild to moderate side effects, similar to those with standard radiation treatments.

This trial is in an early phase, focusing mainly on ensuring safety and understanding side effects. Although this is a new application of the treatment, MRI-guided techniques have demonstrated safety in other contexts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MRI-guided internal radiation therapy for cervical and vaginal cancer because it offers a more precise and personalized treatment approach. Unlike traditional radiation therapy, which can affect surrounding healthy tissues, this method uses MRI imaging to guide the placement of the radiation applicator, targeting the tumor more accurately. This precision minimizes damage to healthy cells and potentially reduces side effects, which could improve the overall quality of life for patients. Additionally, the high-resolution imaging provided by MRI allows for real-time adjustments during treatment, ensuring the most effective dose of radiation is delivered directly to the cancerous area.

What evidence suggests that MRI-guided internal radiation therapy is effective for cervical and vaginal cancer?

Research has shown that MRI-guided internal radiation therapy, or brachytherapy, holds promise for treating cervical and vaginal cancer. Studies have found that MRI guidance can improve treatment planning and may lead to better outcomes compared to older methods. New evidence suggests this approach effectively targets cancer while minimizing harm to nearby healthy tissues. MRI-guided brachytherapy surpasses traditional two-dimensional techniques, offering greater precision and effectiveness. This treatment plays a crucial role in managing advanced cervical cancer, and early findings support its potential benefits. Participants in this trial will undergo MRI scans during internal radiation therapy applicator placement to evaluate these potential benefits. ^{1 2 4 6 7}

Who Is on the Research Team?

Ann H. Klopp

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for women with stage IB2-IVA cervical cancer or stage II-IVA vaginal cancer, recommended to receive chemoradiation including brachytherapy. It's not suitable for those with non-MRI-compatible anatomy, pacemakers, defibrillators, or conditions that prevent MRI use.

Inclusion Criteria

Women with advanced stage cervical cancer who are recommended to receive a specific type of treatment called chemoradiation, including brachytherapy.

Women with a specific stage of vaginal cancer who are advised to undergo a specific type of treatment involving chemotherapy and radiation therapy.

Exclusion Criteria

Patient or tumor anatomy that requires use of a non-MRI-compatible applicator

Patients with implantable cardioverter-defibrillator, pacemaker or other implanted device or medical condition which precludes MRI acquisition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo MRI-guided internal radiation therapy (brachytherapy) for cervical or vaginal cancer

Up to 4 years

Multiple visits for MRI scans and brachytherapy sessions

Follow-up

Participants are monitored for safety, effectiveness, and disease recurrence after treatment

Up to 4 years

Interval follow-up visits with axial imaging (MRI or PET/CT)

What Are the Treatments Tested in This Trial?

Interventions

• Internal Radiation Therapy
• MRI-Guided Brachytherapy

Trial Overview The study tests if using MRI guidance to place the internal radiation therapy device (brachytherapy) can improve treatment planning and outcomes in participants with HPV-associated cervical or vaginal cancers.

How Is the Trial Designed?

Group I: Treatment (MRI, internal radiation therapy) Experimental Treatment 2 Interventions

Participants undergo MRI scan during internal radiation therapy applicator placement.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

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

Magnetic resonance imaging-guided brachytherapy for ... ... MRI-guided brachytherapy may improve clinical outcomes in cervical cancer. To implement a high quality image guided brachytherapy program, a ...

2. 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 ...

3. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/rg.230052

MRI-guided Pelvic Radiation Therapy: A Primer for ... Brachytherapy facilitates the best outcomes of locally advanced cervical cancer, but if it is not technically feasible or the patient is ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24005954

Image-guided brachytherapy in cervical cancer including ... Emerging evidence from prospective studies shows a high rate of local control throughout all stages, superior to two-dimensional brachytherapy, with limited ...

5. mdpi.com mdpi.com/2072-6694/16/5/1031

Current Status and Future Directions of Image-Guided ... Brachytherapy is a key component of radiation treatment in the curative treatment of locally advanced cervical cancer.

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

Magnetic Resonance Image Guided Brachytherapy Clinical improvements in cervix cancer outcomes have been linked to the application of repeated MRI for identification of residual tumor volumes during ...

7. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-023-02240-5

modifying our EMBRACE during the COVID pandemic Safety and efficacy of single insertion accelerated MR-image guided brachytherapy following chemo–radiation in locally advanced cervix cancer: ...