MRI Monitoring for Oral Cancer

Overseen By Stephen Y. Lai

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Low GFR, MRI intolerance, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

425 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how MRI scans after radiation or surgery might predict changes in the tissue around oral or skull base tumors. The goal is to determine if MRIs can foresee osteoradionecrosis, a condition where non-cancerous tissue changes due to radiation. Participants are divided into two groups: one receives an MRI after radiation therapy, and the other after surgery. This trial may suit individuals treated for oral or skull base tumors with radiation who are currently in good health. Participants should not have any non-MRI-safe metal implants. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand how it benefits more patients.

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.

What is the safety track record for Magnetic Resonance Imaging?

Research has shown that magnetic resonance imaging (MRI) is generally safe and manageable for most people. Many studies have found that MRI effectively detects changes in tissues, including those affected by cancer. Unlike some other imaging methods, MRI does not use harmful radiation, enhancing its safety.

Sometimes, a special dye called a contrast agent is used during the MRI to clarify the images. For most people, this dye is safe, though a few might experience mild side effects like warmth or a slight headache.

Overall, MRI is a widely used and trusted tool in medical settings, including for individuals with tumors in the mouth or skull area. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using MRI monitoring for oral cancer because it offers a non-invasive way to track the disease's progress and response to treatments like surgery and radiation. Unlike traditional methods that might rely heavily on physical exams or biopsies, MRI provides detailed images of the soft tissues in the mouth, potentially catching changes earlier and more accurately. This approach could lead to earlier interventions and better long-term outcomes for patients. By using MRI at multiple stages—before and after standard treatments—doctors hope to better understand how oral cancer behaves and how to tailor future treatments more effectively.

What evidence suggests that MRI is effective for predicting radiation-induced changes in oral cancer patients?

Research has shown that magnetic resonance imaging (MRI) effectively diagnoses and monitors changes in body tissues. Studies have found that MRI is 93% accurate in detecting and ruling out jawbone changes related to oral cancers. In this trial, participants will be divided into two cohorts to evaluate MRI's effectiveness in different contexts. Cohort I will undergo MRI after radiation therapy to identify early signs of tissue damage, such as bone tissue damage caused by radiation. Cohort II will have MRI after surgery, providing detailed information to help doctors manage and prevent complications in patients with oral and skull base tumors. MRI can precisely assess the depth and extent of a tumor in the mouth, making it a reliable tool for predicting tissue changes after treatments. ^{4 6 7 8 9}

Who Is on the Research Team?

Stephen Y. Lai

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with confirmed malignant tumors in the oral cavity or skull base who have had or will have radiation therapy. They must be able to perform daily activities (ECOG score 0-2) and consent to participate. Those unable to undergo certain MRI scans, with poor kidney function, or incompatible implants cannot join.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

Patients willing to give written informed consent

I have a confirmed cancer in my mouth or skull base.

Exclusion Criteria

I cannot undergo certain MRI scans or my kidney function is low.

Patients with contraindication to MRI (e.g. non-MRI compatible metallic implants)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Patients undergo standard of care radiation therapy and receive MRIs at baseline, 3-5 weeks after starting therapy, and at 2 months, 6 months, 12 months, and 3 years after completing therapy

3 years

Multiple visits for MRI at specified intervals

Follow-up

Participants are monitored for radiation-induced changes in normal tissue using MRI

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Magnetic Resonance Imaging

Trial Overview The study is testing if serial MRIs after radiation can predict changes in non-cancerous tissue potentially leading to osteoradionecrosis in patients with oral cavity or skull base tumors. It involves contrast agents, quality-of-life assessments, and questionnaires.

How Is the Trial Designed?

Group I: Cohort II (MRI after surgery) Experimental Treatment 4 Interventions

Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, and at 5-10 weeks and 12 months after standard of care surgery.

Group II: Cohort I (MRI after radiation therapy) Experimental Treatment 4 Interventions

Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, 3-5 weeks after starting standard of care radiation therapy, and then at 2 months, 6 months, 12 months, and 3 years after completing radiation therapy.

Magnetic Resonance Imaging is already approved in United States for the following indications:

Approved in United States as Lumakras (sotorasib) for:

• Non-small cell lung cancer with KRAS G12C mutation

Approved in United States as Vectibix (panitumumab) for:

• Advanced colorectal cancer that is wild-type RAS

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+

Published Research Related to This Trial

The study developed a workflow for MRI-guided volumetric arc therapy (VMAT) in a rabbit model, demonstrating its safety and feasibility for radiation therapy planning.

MRI-guided RT showed improved tumor targeting and reduced damage to surrounding healthy tissues compared to conventional 2D radiation therapy, highlighting its potential for better treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Validation of a Clinically Relevant Workflow for MR-Guided Volumetric Arc Therapy in a Rabbit Model of Head and Neck Cancer. Rajab Bolookat, E., Malhotra, H., Rich, LJ., et al.[2021]

Real-time magnetic resonance imaging (rtMRI) can significantly enhance oral and maxillofacial surgery by providing a temporal resolution of 70 frames per second, allowing for better procedure planning and monitoring compared to conventional MRI, which has a much lower resolution and longer scanning times.

The development of rtMRI is in its preliminary stages, focusing on interdisciplinary collaboration to create innovative diagnostic tools that could improve patient outcomes in head and neck cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time magnetic resonance imaging: mechanics of oral and facial function. Kennerley, AJ., Mitchell, DA., Sebald, A., et al.[2022]

In a study of 22 oral cancer patients treated with intensity-modulated radiation therapy (IMRT), 77.3% experienced varying degrees of trismus, indicating a common post-operative complication.

The study found that MRI-derived signal abnormality scores (SA scores) correlated with the severity of trismus and could predict outcomes with high sensitivity (100%) and specificity (93%), suggesting that these scores, along with radiation dose, can be valuable biomarkers for managing trismus after radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting the severity and prognosis of trismus after intensity-modulated radiation therapy for oral cancer patients by magnetic resonance imaging. Hsieh, LC., Chen, JW., Wang, LY., et al.[2021]

In a study involving patients with oral tongue squamous cell carcinoma (OTSCC), the DCE-MRI parameter Kep was found to be a significant predictor of advanced tumor stages, with lower values observed in more advanced stages (III-IV) compared to earlier stages (I-II).

Kep demonstrated a predictive capability with a sensitivity of 64.3% and specificity of 82.6%, suggesting it can serve as a reliable biomarker for assessing the pathologic stages of OTSCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative dynamic contrast-enhanced MR imaging can be used to predict the pathologic stages of oral tongue squamous cell carcinoma. Guo, N., Zeng, W., Deng, H., et al.[2021]

A study involving 14 healthy volunteers demonstrated that a highly-accelerated 3D MRI can effectively measure positional shifts during MR-guided radiotherapy for head and neck treatments, maintaining accuracy in position verification.

The results showed that the accuracy of the highly-accelerated MRI was comparable to standard high-resolution MRI, indicating it can be a viable option for improving the efficiency of radiotherapy without sacrificing precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of highly accelerated 3D MRI in the head and neck position verification for MR-guided radiotherapy. Zhou, Y., Wong, OL., Cheung, KY., et al.[2022]

In a study of 43 patients with oral or oropharyngeal squamous cell carcinoma, MRI demonstrated high sensitivity (93%), specificity (93%), and accuracy (93%) in detecting mandibular involvement, making it a reliable imaging technique for treatment planning.

MRI not only effectively identifies soft-tissue involvement but also provides significant diagnostic value in detecting bony invasion, confirming its role as the preferred imaging method in advanced cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of magnetic resonance imaging in the assessment of mandibular involvement in oral-oropharyngeal squamous cell carcinoma: a prospective study. Bolzoni, A., Cappiello, J., Piazza, C., et al.[2022]

In a study of 49 patients with buccal squamous cell carcinoma, MRI was found to have a significant difference in measuring the depth of invasion (DOI) compared to pathological sections, with an average discrepancy of 5.55 mm.

MRI-derived DOI values greater than 8.5 mm indicate a need for simultaneous neck dissection during initial surgery, and buccinator invasion was identified as an important prognostic factor for overall and disease-specific survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of Magnetic Resonance Imaging in Evaluating the Depth and Level of Invasion of Buccal Carcinoma: A Prospective Cohort Study. Wang, Y., Mao, M., Li, J., et al.[2022]

This review highlights the potential of real-time MR imaging during radiotherapy to monitor changes in organs at risk (OARs) without additional patient burden, which could improve treatment safety and efficacy.

The analysis focused on head and neck cancer patients and included various MRI techniques to assess RT-induced changes in normal tissues, emphasizing the need for more studies with repetitive MRI to better understand the correlation between these changes and treatment toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive MRI of organs at risk in head and neck cancer patients undergoing radiotherapy. Stieb, S., Elgohari, B., Fuller, CD.[2020]

MRI is an effective tool for accurately identifying and delineating primary squamous cell carcinoma in the oral and maxillofacial regions, particularly when using postcontrast T1-weighted imaging, which enhances sensitivity for unclear tumor margins.

In a study of 70 patients, MRI showed a high concordance rate (86%) with histopathological classifications in untreated cases, indicating its reliability in assessing tumor characteristics and infiltration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A study on MRI diagnosis for primary squamous cell carcinoma in oral and maxillofacial regions]. Yagihara, K.[2019]

Preoperative contrast-enhanced MRI is highly accurate in assessing the depth of invasion (rDOI) and bone invasion in oral cavity cancer, showing a strong correlation with histopathological measurements.

An rDOI greater than 10 mm is linked to poorer disease-specific survival, making it a significant independent predictor of outcomes in patients with oral cavity cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic and prognostic value of magnetic resonance imaging in the detection of tumor depth of invasion and bone invasion in patients with oral cavity cancer. Lo Casto, A., Cannella, R., Taravella, R., et al.[2022]

In a study of 18 patients with head and neck cancers, MRI-guided radiotherapy resulted in a high complete response rate of 83% and excellent 1-year survival rates (96% overall survival).

The treatment was safe, with no fatalities reported, although 44% of patients experienced significant acute toxicity; nonetheless, many reported improved quality of life post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-guided radiotherapy for head and neck cancer: initial clinical experience. Chen, AM., Hsu, S., Lamb, J., et al.[2022]

Magnetic resonance imaging (MR) has a sensitivity of 77.9% and specificity of 82.3% for diagnosing mandibular invasion in oral cancers, based on a meta-analysis of 12 studies involving 476 patients.

The diagnostic odds ratio of 25.702 indicates that MR is a reliable tool for detecting mandibular invasion, making it clinically valuable in the management of oral cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Systematic review of magnetic resonance imaging in diagnosing mandibular invasion caused by oral cancers]. Li, Y., Li, C., Sun, J., et al.[2020]

The use of a 1.5 T MRI-accelerator for radiotherapy in oesophageal cancer allows for superior soft-tissue visualization, enabling precise real-time tracking of tumor movement, which is crucial for effective treatment planning.

In a study involving 15 patients, the MRI sequences demonstrated excellent image quality and the ability to quantify tumor motion, revealing significant variability in movement patterns, particularly in the cranio-caudal direction, which can enhance the safety and efficacy of targeted radiation delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SU-E-J-57: MRI-Linac (MRL) Guided Treatment for Esophageal Cancer. Lips, I., Lever, F., Reerink, O., et al.[2019]

Magnetic resonance imaging (MRI) significantly enhances the visualization of head and neck tumors, allowing for better delineation of tumor boundaries compared to traditional imaging methods like CT.

Using MRI in radiation therapy planning improves treatment accuracy by avoiding artifacts from immobilization casts and enabling imaging in various planes without repositioning the patient, which helps maintain consistency across treatment sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI assisted treatment planning for radiation therapy of the head and neck. Toonkel, LM., Soila, K., Gilbert, D., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6617213/

Utility of CT and MRI in assessment of mandibular ... Combined CT and MRI had a sensitivity of 100% and a specificity of 72%. Conclusion. The results suggest that combined CT and MRI have diagnostic utility in ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0278239121004262

Accuracy of Magnetic Resonance Imaging in Evaluating ... This study evaluated the accuracy of magnetic resonance imaging (MRI) in determining the depth and level of invasion of buccal carcinoma.

3. biomarkerres.biomedcentral.com biomarkerres.biomedcentral.com/articles/10.1186/s40364-023-00494-5

MRI-based radiomic prognostic signature for locally advanced ... Few other MRI-based radiomic studies focused on oral cavity cancer were proposed to predict tumor grading [43], pathological differentiation [44] ...

4. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/647760

Diagnostic Accuracy of Magnetic Resonance Imaging in ... The sensitivity, specificity, and accuracy of MRI in detection of mandibular involvement were 93%, 93%, and 93%, respectively, while the negative and positive ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0177462

Meta-analysis of magnetic resonance imaging accuracy for ... Objective. To establish the diagnostic accuracy of magnetic resonance imaging (MRI) as an auxiliary means for the diagnosis of oral cancer through a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7036512/

Improving Oral Cancer Outcomes with Imaging and ... Combined imaging and artificial intelligence approaches can improve oral cancer outcomes through improved detection and diagnosis. Keywords: oral neoplasms, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5443513/

Meta-analysis of magnetic resonance imaging accuracy for ... The global positive likelihood ratio was 6.5 (95% CI: 3.8–11.0), i.e., a positive traditional MRI result increased by 6.5-fold the odds of an ...

8. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2019.01571/full

Magnetic Resonance vs. Intraoral Ultrasonography in the ... This review aims to analyze the accuracy of MR and intraoral US in determining DOI/TT in oral SCC, by assuming histological evaluation as the reference method.

9. sciencedirect.com sciencedirect.com/science/article/pii/S1368837524001416

A systematic review on intraoperative imaging techniques ... A systematic review on clinical intraoperative whole-specimen imaging techniques to obtain adequate deep resection margins in oral SCC is lacking.