MRI for Diagnosing Osteoradionecrosis in Head and Neck Cancer

Overseen By Stephen> Lai

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Cognitive impairment, Claustrophobia, others

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

Compensation: Varies

Number of Visits: 1

1400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates how effectively a special MRI technique, dynamic contrast-enhanced MRI (DCE-MRI), can detect osteoradionecrosis (ORN) in individuals with head and neck cancer undergoing radiation therapy. This imaging may help doctors predict ORN before it develops into a significant issue. Individuals diagnosed with head and neck cancer who are about to start or have already begun radiation therapy might qualify for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance early detection of ORN.

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 prior data suggests that dynamic contrast-enhanced magnetic resonance imaging is safe for diagnosing osteoradionecrosis?

Research has shown that dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) is generally safe. DCE-MRI uses a special dye to highlight blood flow in tissues during an MRI scan, which is particularly useful for examining blood vessels in areas like the head and neck.

Studies have found that DCE-MRI effectively measures changes in blood flow and blood vessel permeability. This aids doctors in understanding conditions like osteoradionecrosis, a bone issue that can occur after radiation therapy. These studies have reported no major problems directly linked to DCE-MRI.

While specific side effects are not detailed in the sources, the widespread use of DCE-MRI in studies and medical imaging suggests it is well-tolerated. As with any medical procedure, patients should discuss any concerns with their doctors, but current research supports the safety of DCE-MRI in clinical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) for diagnosing osteoradionecrosis in head and neck cancer patients because it offers a non-invasive way to visualize tissue changes in real-time. Unlike traditional imaging methods, DCE-MRI provides detailed insights into blood flow and tissue perfusion, which can help identify changes early and more accurately. This could lead to better treatment planning and improved outcomes for patients by catching complications sooner and monitoring the effectiveness of treatments over time.

What evidence suggests that DCE-MRI is effective for diagnosing osteoradionecrosis in head and neck cancer?

Research has shown that a special type of MRI scan, called Dynamic Contrast-Enhanced MRI (DCE-MRI), holds promise for diagnosing bone damage caused by radiation in head and neck cancer patients. In this trial, participants will undergo DCE-MRI at various stages to evaluate its effectiveness in detecting radiation-induced blood vessel damage, a key indicator of bone damage. This scan also helps in understanding potential cancer progression. By identifying these changes early, doctors can better predict and manage bone damage. Early findings suggest that DCE-MRI could become an important tool for improving care for patients receiving radiation therapy. ^{1 2 3 6 7}

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 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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Dynamic Contrast-Enhanced Magnetic Resonance Imaging
• Questionnaire Administration

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.

How Is the Trial Designed?

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03145077

NCT03145077 | Dynamic Contrast-Enhanced Magnetic ... This trial studies how well dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) works in diagnosing osteoradionecrosis in patients with head and ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32712257/

Quantitative Dynamic Contrast-Enhanced MRI Identifies ... Quantitative Dynamic Contrast-Enhanced MRI Identifies Radiation-Induced Vascular Damage in Patients With Advanced Osteoradionecrosis: Results of ...

3. nature.com nature.com/articles/sdata20188

Dynamic contrast-enhanced magnetic resonance imaging ... Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) has been correlated with prognosis in head and neck squamous cell carcinoma as well as with ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2405631624001593

Translation of dynamic contrast-enhanced imaging onto a ... DCE-MRI is feasible on a 1.5 T MRI-linac in head and neck cancer. •. DCE-MRI derived parameters are comparable between a MRI-linac and a 1.5 T diagnostic MR ...

5. grantome.com grantome.com/grant/NIH/R01-DE025248-01A1

Using Dynamic Contrast-Enhanced Magnetic Resonance ... The proposed clinical research will use dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) to assess the natural history of osteoradionecrosis (ORN) ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301611028069

Dynamic Contrast-Enhanced MRI in Head-and-Neck Cancer Dynamic contrast–enhanced (DCE) MRI-extracted parameters measure tumor microvascular physiology and are usually calculated from an intratumor region of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7680450/

Quantitative Dynamic Contrast-Enhanced MRI Identifies ... Boxplots showing the comparison of dynamic contrast-enhanced magnetic resonance imaging parameters between osteoradionecrosis and control volumes of interest.