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

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies how well magnetic resonance imaging (MRI)-guided internal radiation therapy (brachytherapy) works in treating participants with human papillomavirus (HPV) associated stage IB2-IV cervical or stage II-IVA vaginal cancer. Using MRI guidance during brachytherapy applicator placement may improve treatment planning in participants with cervical or vaginal cancer.

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.

Is MRI-guided internal radiation therapy safe for humans?

MRI-guided brachytherapy for cervical cancer has been associated with late side effects, and high-grade toxicities have been reported, although improvements in the technique have reduced these compared to older methods. ^{1 2 3 4 5}

How is MRI-guided internal radiation therapy for cervical and vaginal cancer different from other treatments?

MRI-guided internal radiation therapy, also known as brachytherapy, is unique because it uses MRI to precisely target the tumor, allowing for better dose optimization to the cancer while minimizing exposure to surrounding healthy organs. This approach can improve treatment accuracy and reduce side effects compared to traditional methods that may not use MRI for guidance. ^{2 3 6 7 8}

What data supports the effectiveness of the treatment MRI-Guided Internal Radiation for Cervical and Vaginal Cancer?

Research shows that MRI-guided brachytherapy, a type of internal radiation, can significantly reduce tumor size in cervical cancer patients, with 11 out of 15 patients experiencing more than 80% tumor shrinkage. MRI helps in precisely targeting the cancer while minimizing damage to nearby organs, making it a valuable tool in treatment planning. ^{2 3 7 9 10}

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. England pubmed.ncbi.nlm.nih.gov

Preliminary results of MRI-guided brachytherapy in cervical carcinoma: the Chiangmai University experience. [2019]

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

The Potential Value of MRI in External-Beam Radiotherapy for Cervical Cancer. [2019]

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

Implementing MRI-based target delineation for cervical cancer treatment within a rapid workflow environment for image-guided brachytherapy: A practical approach for centers without in-room MRI. [2022]

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

Role of MRI in intracavitary brachytherapy for cervical cancer: what the radiologist needs to know. [2013]

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

MRI for Radiation Therapy Planning in Human Papillomavirus-associated Gynecologic Cancers. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

Late side effects of 3T MRI-guided 3D high-dose rate brachytherapy of cervical cancer : Institutional experiences. [2020]

7. Poland pubmed.ncbi.nlm.nih.gov

How one institution overcame the challenges to start an MRI-based brachytherapy program for cervical cancer. [2022]

8. Australia pubmed.ncbi.nlm.nih.gov

High-risk CTV delineation for cervix brachytherapy: Application of GEC-ESTRO guidelines in Australia and New Zealand. [2017]

9. 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]

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

MR imaging during intracavitary brachytherapy of vaginal and cervical cancer: preliminary results. [2005]