MRI for Diagnosing Osteoradionecrosis in Head and Neck Cancer

Overseen by Stephen Y. Lai

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Cognitive impairment, Claustrophobia, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial studies how well dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) works in diagnosing osteoradionecrosis in patients with head and neck cancer that is primary, has come back, or has spread to other places in the body who are undergoing radiation therapy. DCE-MRI may help doctors to predict osteoradionecrosis in patient with head and neck cancer undergoing radiation therapy.

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 Dynamic Contrast-Enhanced Magnetic Resonance Imaging for diagnosing osteoradionecrosis in head and neck cancer?

Research shows that Dynamic Contrast-Enhanced MRI can detect changes in blood flow in the jawbone during radiation therapy for head and neck cancer, which may help identify early signs of tissue damage. ^{1 2 3 4 5}

Is Dynamic Contrast-Enhanced MRI safe for humans?

Dynamic Contrast-Enhanced MRI (DCE-MRI) has been used in studies to monitor changes in tissue during radiation therapy for head and neck cancer, and no specific safety concerns have been reported in these studies. It is generally considered safe for humans, but as with any medical procedure, it should be performed under the guidance of a healthcare professional. ^{2 4 6 7 8}

How does MRI differ from other treatments for diagnosing osteoradionecrosis in head and neck cancer?

MRI is unique because it provides detailed images of the head and neck, allowing for better visualization of tumors and changes in bone vascularity during treatment. Unlike other imaging methods, MRI can detect real-time changes in bone blood flow, which is crucial for identifying and managing osteoradionecrosis. ^{2 6 9 10 11}

Research Team

Stephen Y. Lai

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients with head and neck cancer, either new or recurrent, who are undergoing radiation therapy. Participants must be willing to consent and follow study procedures throughout the duration. They should have a good performance status (able to carry out daily activities) and not have been diagnosed with osteoradionecrosis at enrollment. Exclusions include poor kidney function, claustrophobia, pregnancy, cognitive impairment, non-MRI compatible implants, or previous multiple radiotherapies for head and neck malignancies.

Inclusion Criteria

Willing and able to provide informed consent

I had radiotherapy for cancer, with or without chemotherapy.

I have recurring or new head and neck cancer and will undergo more radiation to try to cure it.

Exclusion Criteria

I cannot get clear scans to check for specific cancer markers.

I had radiotherapy for cancer in my head or neck, not including skin cancer.

Pregnant females and cognitively impaired patients

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Radiation Therapy

Patients undergo DCE-MRI within 4 weeks prior to the first radiation fraction, within 3-5 weeks after radiation start, and at 2, 6, 12, 24, and 36 months post radiation

36 months

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with DCE-MRI scans at 6, 12, 24, 36, and/or 48 months post radiation

48 months

Yearly visits (in-person)

Long-term Follow-up

Patients in the third or subsequent years post treatment may undergo subsequent yearly imaging studies

Ongoing

Treatment Details

Interventions

• Dynamic Contrast-Enhanced Magnetic Resonance Imaging (Procedure)
• Questionnaire Administration (Other)

Trial Overview The trial is testing how well dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) can predict bone damage caused by radiation therapy in patients with head and neck cancer. It involves different groups: those about to start radiation therapy; those already treated; those showing early signs of bone damage; and those needing surgery due to severe bone damage.

Participant Groups

Group I: Cohort 4 (DCE-MRI) Experimental Treatment 2 Interventions

Patients undergo DCE-MRI within 4 weeks prior to and at 5-10 weeks and 12 months post surgery.

Group II: Cohort 3 (DCE-MRI) Experimental Treatment 2 Interventions

Patients undergo DCE-MRI before and at 2 and 6 months post ORN treatment. Patients may undergo DCE-MRI during the mid-ORN treatment.

Group III: Cohort 2 (DCE-MRI) Experimental Treatment 2 Interventions

Patients undergo DCE-MRI within 4 weeks prior to the first re-radiation fraction, within 3-5 weeks after radiation start, and at 2, 6, 12, 24, and 36 months post radiation.

Group IV: Cohort 1 (DCE-MRI) Experimental Treatment 2 Interventions

Patients with newly diagnosed tumors undergo DCE-MRI within 4 weeks prior to the first radiation fraction, within 3-5 weeks after radiation start, and at 2, 6, 12, 24, and 36 months post radiation. Patients who were previously irradiated and are at various stages of oncologic follow-up undergo DCE-MRI for a total of 2-5 times at baseline and at 6, 12, 24, 36, and/or 48 months post radiation. Patients in the third or subsequent years post treatment may undergo subsequent yearly imaging studies.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Janice S. Lee

National Institute of Dental and Craniofacial Research (NIDCR)

Clinical Director

DDS, MD, MS

Jennifer Webster-Cyriaque

National Institute of Dental and Craniofacial Research (NIDCR)

Acting Director

DDS, PhD

Findings from Research

Baseline magnetic resonance imaging (b-MRI) radiomic features can effectively predict disease recurrence and survival outcomes in patients with head and neck squamous cell carcinoma (HNSCC), with a sensitivity of 82% and specificity of 78% in the training set.

Combining radiomic features with traditional clinical factors (like TNM staging) significantly enhances prognostic accuracy for 5-year disease-free survival and overall survival, indicating that radiomics can provide valuable insights beyond standard clinical assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic role of pre-treatment magnetic resonance imaging (MRI)-based radiomic analysis in effectively cured head and neck squamous cell carcinoma (HNSCC) patients. Alfieri, S., Romanò, R., Bologna, M., et al.[2022]

Dynamic Contrast-Enhanced MRI (DCE-MRI) can detect real-time changes in the vascularity of mandibular bone during external beam radiotherapy (EBRT) for head and neck cancer, which is crucial for minimizing normal tissue toxicity.

In a study of 32 patients, DCE-MRI identified dose-dependent alterations in bone vascularity, suggesting it could serve as a valuable tool for monitoring treatment effects and potential complications like osteoradionecrosis (ORN).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic contrast-enhanced MRI detects acute radiotherapy-induced alterations in mandibular microvasculature: prospective assessment of imaging biomarkers of normal tissue injury. [2022]

Dynamic contrast-enhanced MRI (DCE MRI) can effectively predict treatment response in patients with advanced head and neck cancers, as shown in a study of 21 patients undergoing chemoradiotherapy.

Higher blood flow and volume measurements were associated with complete responders compared to partial responders, suggesting that DCE MRI metrics could help identify which patients are more likely to benefit from treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exploratory study into the role of dynamic contrast-enhanced (DCE) MRI metrics as predictors of response in head and neck cancers. Agrawal, S., Awasthi, R., Singh, A., et al.[2015]

Using a planning MRI (pMRI) in the treatment position for oropharyngeal cancer patients improved the registration quality and efficiency of target volume delineation compared to diagnostic MRI (dMRI), with modifications made for 19 out of 26 patients.

The pMRI resulted in larger target volumes, which may reduce the ability to spare surrounding organs during radiation therapy, indicating a trade-off between improved targeting and potential risks to healthy tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the impact of magnetic resonance treatment simulation (MRSIM) on target volume delineation and dose to organs at risk for oropharyngeal radiotherapy. Richardson, H., Kumar, M., Tieu, MT., et al.[2022]

MRI demonstrates good diagnostic accuracy for detecting lymph node metastases in head and neck squamous cell carcinoma (HNSCC), with a sensitivity of 76% and specificity of 86% based on a meta-analysis of 16 studies.

Diffusion-weighted imaging (DWI) within MRI shows improved sensitivity (86%) compared to conventional MRI techniques, suggesting it may be a superior method for nodal staging in HNSCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value of magnetic resonance imaging for nodal staging in patients with head and neck squamous cell carcinoma: a meta-analysis. Wu, LM., Xu, JR., Liu, MJ., et al.[2012]

Dynamic magnetic resonance imaging (MRI) demonstrated high accuracy (94.4%) in evaluating treatment responses in head and neck cancers after radiation therapy, correctly identifying remission and response levels in most patients.

The study involved 76 patients with various types of head and neck cancers, and dynamic MRI outperformed other imaging techniques, making it a valuable tool for assessing the effectiveness of radiation therapy combined with low-dose cisplatinum.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of dynamic MRI in the evaluation of head and neck cancers treated with radiation therapy. Baba, Y., Furusawa, M., Murakami, R., et al.[2019]

Dynamic contrast-enhanced MRI (using maximum slope of increase, MSI) effectively correlates with histological grading of radiation response in head and neck cancer, showing significant differences in MSI values between viable and non-viable tumor cells.

In this study of 27 patients, those with no tumor cells (grade 4) had a markedly lower MSI (1.8) compared to those with viable tumor cells (grades 2 and 3, average MSI of 7.4), indicating that MSI can be a useful tool for evaluating treatment response post-radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic contrast-enhanced magnetic resonance imaging in radiotherapeutic efficacy in the head and neck tumors. Tomura, N., Omachi, K., Sakuma, I., et al.[2019]

In a study involving 40 patients with oropharyngeal squamous cell carcinoma, both Intravoxel Incoherent Motion Diffusion Weighted Imaging (IVIM-DWI) and Dynamic Contrast-Enhanced (DCE) MRI were effective in detecting and predicting early volumetric changes in parotid glands during and shortly after (chemo)radiotherapy.

The study found that changes in parotid volume were significantly correlated with imaging parameters like the apparent diffusion coefficient (ADC) and tissue diffusion coefficient (Dt), suggesting that these imaging techniques can provide valuable insights into the effects of treatment on salivary glands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation-induced parotid changes in oropharyngeal cancer patients: the role of early functional imaging and patient-/treatment-related factors. Marzi, S., Farneti, A., Vidiri, A., et al.[2018]

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]

The study found that the image quality for MRI in radiotherapy setups is lower than in diagnostic setups, with a signal-to-noise ratio (SNR) that is 1.3 times higher in diagnostic conditions, indicating a need for improved imaging protocols in radiotherapy.

An optimized MRI protocol was developed that provides accurate images for dose-planning in head-and-neck radiotherapy, achieving a mean absolute error of 82.8 HU in generated pseudo-CTs, which can enhance clinical practice in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Head-and-Neck MRI-only radiotherapy treatment planning: From acquisition in treatment position to pseudo-CT generation. Largent, A., Marage, L., Gicquiau, I., et al.[2020]

Dynamic magnetic resonance (MR) imaging was performed on 79 head and neck lesions, but it did not improve the sensitivity for detecting malignancy compared to traditional imaging methods.

While dynamic imaging did not effectively differentiate between benign and malignant lesions, it may help in assessing vascularity and recurrence risk, particularly for lesions with specific signal intensity curve patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic MR imaging in the head and neck. Takashima, S., Noguchi, Y., Okumura, T., et al.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

Prognostic role of pre-treatment magnetic resonance imaging (MRI)-based radiomic analysis in effectively cured head and neck squamous cell carcinoma (HNSCC) patients. [2022]

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

Dynamic contrast-enhanced MRI detects acute radiotherapy-induced alterations in mandibular microvasculature: prospective assessment of imaging biomarkers of normal tissue injury. [2022]

3. England pubmed.ncbi.nlm.nih.gov

An exploratory study into the role of dynamic contrast-enhanced (DCE) MRI metrics as predictors of response in head and neck cancers. [2015]

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

Assessing the impact of magnetic resonance treatment simulation (MRSIM) on target volume delineation and dose to organs at risk for oropharyngeal radiotherapy. [2022]

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

Value of magnetic resonance imaging for nodal staging in patients with head and neck squamous cell carcinoma: a meta-analysis. [2012]

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

Role of dynamic MRI in the evaluation of head and neck cancers treated with radiation therapy. [2019]

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

Dynamic contrast-enhanced magnetic resonance imaging in radiotherapeutic efficacy in the head and neck tumors. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Radiation-induced parotid changes in oropharyngeal cancer patients: the role of early functional imaging and patient-/treatment-related factors. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

MRI assisted treatment planning for radiation therapy of the head and neck. [2019]

10. France pubmed.ncbi.nlm.nih.gov

Head-and-Neck MRI-only radiotherapy treatment planning: From acquisition in treatment position to pseudo-CT generation. [2020]

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

Dynamic MR imaging in the head and neck. [2015]