MRI and Biomarker Monitoring for Head and Neck Cancer

Overseen By Clifton D. Fuller

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Previous radiation, Pregnancy, Claustrophobia, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if additional MRIs and blood tests can predict changes in head and neck tumors during radiation therapy. Researchers examine biomarkers, including genetic ones, to understand tumor behavior. Participants with squamous cell carcinoma of the head and neck, who have not undergone major surgery or previous radiation for these cancers, might qualify. The study includes MRIs (Magnetic Resonance Imaging) and blood samples taken before, during, and after radiation therapy at MD Anderson.

As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in cancer care.

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 this MRI and biomarker monitoring is safe for head and neck cancer patients?

Research has shown that using MRI scans for head and neck cancer is generally safe. An MRI uses magnets and radio waves to capture images inside the body. Studies have found that MRIs can detect changes in tumors during radiation treatment.

Before an MRI, patients undergo a safety check to ensure the scan is safe for them, identifying any potential risks. Most patients tolerate MRIs well, though some might feel uncomfortable or anxious inside the machine. Serious issues are rare.

As part of this study, researchers will also collect blood samples. This involves drawing a small amount of blood to test for biomarkers, which indicate how the body responds to treatment. Blood draws are usually safe, with only minor risks like slight bruising at the needle site.

Overall, both MRIs and blood tests are considered safe, with minimal risks involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to monitor head and neck cancer using MRI and biomarker testing. Unlike traditional treatments that primarily focus on eradicating tumors through surgery, radiation, or chemotherapy, this protocol aims to enhance our understanding of how tumors respond to treatment in real-time. By regularly collecting MRI scans and blood samples, researchers hope to identify specific biomarkers that could predict treatment outcomes and tailor therapies more effectively. This approach could lead to more personalized treatment plans, potentially improving patient quality of life and treatment success rates.

What evidence suggests that using additional MRIs and biomarker testing is effective for monitoring head and neck cancer?

Research has shown that MRIs play a crucial role in understanding head and neck cancer. They help doctors assess the extent of cancer spread and assist in treatment planning. In this trial, participants will undergo MRI scans as part of the diagnostic arm, which also includes blood sample collection for biomarker testing. One study found that combining MRI results with other medical information improved predictions about patient responses to treatment. Another study identified specific MRI patterns that could help predict cancer behavior. While MRIs alone may not improve outcomes, they provide valuable information that guides treatment planning. ^{6 7 8 9 10}

Who Is on the Research Team?

Clifton D. Fuller

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with certain head and neck cancers who haven't had distant metastases or previous radiation treatments in the affected area. They should be fit enough for curative radiotherapy, not pregnant, and able to undergo MRI scans without contraindications like metal implants or severe kidney issues.

Inclusion Criteria

I have not had surgery on my head or neck cancer, except for biopsy.

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

I am of child-bearing age and my pregnancy test is negative.

Exclusion Criteria

I had radiation for head or neck cancer in the last 5 years.

Pregnant or breast-feeding females

Contraindications to magnetic resonance (MR) imaging

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-radiation

Patients undergo MRI scans and collection of blood samples for biomarker testing before radiation therapy

1 week

1 visit (in-person)

Radiation Therapy

Weekly MRI scans and blood sample collection for biomarker testing during radiation therapy

6-7 weeks

Weekly visits (in-person)

Post-radiation Follow-up

MRI scans and blood sample collection for biomarker testing at 2-3 months post-radiation therapy

2-3 months

1-2 visits (in-person)

Long-term Follow-up

Participants are monitored for locoregional control and disease-free survival

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Biospecimen Collection
• Magnetic Resonance Imaging
• Quality-of-Life Assessment

Trial Overview Researchers are testing if additional MRIs and blood biomarker analysis can predict tumor changes during radiation therapy. Participants will have extra scans and blood tests beyond standard care to see if these methods improve understanding of treatment response.

How Is the Trial Designed?

Group I: Diagnostic (MRI, blood sample collection) Experimental Treatment 4 Interventions

Patients undergo MRI scans and collection of blood samples for biomarker testing pre-radiation therapy, weekly during radiation therapy, and at 2-3 months post-radiation therapy.

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

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]

Diffusion-weighted imaging (DWI) sequences on an MR-linac system showed comparable performance to those on a traditional MR simulator, indicating their potential for monitoring treatment response in head and neck cancers.

The study involved 20 participants (10 cancer patients and 10 healthy volunteers) and demonstrated good repeatability and reproducibility of DWI measurements, suggesting that these imaging techniques could be reliable for clinical use in adaptive radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of in vivo and phantom repeatability and reproducibility of diffusion-weighted MRI sequences on 1.5 T MRI-linear accelerator (MR-Linac) and MR simulator devices for head and neck cancers. McDonald, BA., Salzillo, T., Mulder, S., et al.[2023]

A prospective feasibility study was conducted to evaluate the use of ferumoxytol as a contrast agent for dynamic contrast-enhanced MRI in patients with node-positive head and neck squamous cell carcinomas (HNSCC) or melanoma, involving five enrolled patients.

The study was prematurely terminated due to an FDA black box warning, but it aimed to provide valuable clinical and imaging data for future research in molecular imaging despite the early halt.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data from a terminated study on iron oxide nanoparticle magnetic resonance imaging for head and neck tumors. Elhalawani, H., Awan, MJ., Ding, Y., et al.[2021]

Diffusion weighted magnetic resonance imaging (DW-MRI) demonstrated high accuracy in distinguishing persistent or recurrent head and neck squamous cell carcinoma (HNSCC) from non-tumoral changes after treatment, with an impressive sensitivity of 94.6% and specificity of 95.9%.

Compared to other imaging methods like computed tomography and PET scans, DW-MRI produced fewer false positives, making it a more reliable tool for detecting cancer recurrence and identifying small metastatic lymph nodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of head and neck squamous cell carcinoma with diffusion weighted MRI after (chemo)radiotherapy: correlation between radiologic and histopathologic findings. Vandecaveye, V., De Keyzer, F., Nuyts, S., et al.[2021]

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]

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]

Citations

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Clinical validation of a prognostic preclinical magnetic ... A total of 31 HNC patients underwent T2-weighted and DW-MRI using 3 T MRI before radiochemotherapy (35 x 2 Gy). Gross tumor volumes (GTV) were ...

2. nature.com nature.com/articles/s41598-024-60009-6

MRI radiomics in head and neck cancer from ... This study aimed to identify and replicate published, reproducible radiomic signatures based on magnetic resonance imaging (MRI), for prognosis ...

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Posttreatment Surveillance Imaging for Head and Neck ... Findings In this comparative effectiveness research study of 340 patients, imaging-based surveillance was not associated with improved outcomes ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1805057/

Head and neck cancer: how imaging predicts treatment ... Computed tomography (CT) and magnetic resonance imaging (MRI) assist in pre-treatment planning by better defining the extent of the primary tumour and by ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405631625000648

Improving outcome prediction in oropharyngeal carcinoma ... Combining clinical and radiomic data resulted in a C-index of 0.72 (0.65–0.80), with GLCM-correlation, disease stage and alcohol use as significant predictors.

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Incidental findings and safety events from magnetic ... This study retrospectively reviews the incidental findings and safety events that were observed at a single institution during introduction of MRI sim for head ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2405631624001635

Quantitative magnetic resonance imaging responses in ... Quantitative MRI (qMRI) has been explored for detecting tumor changes during radiation therapy (RT) in head and neck squamous cell cancer (HNSCC).

8. 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 ...

9. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK551669/

Magnetic Resonance Imaging Contraindications - NCBI - NIH All patients must complete a thorough safety screening before undergoing an MRI scan due to potential safety risks. The screening process ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT03483337

New MRI Biomarkers in Head and Neck Cancers The study is designed to determine if the MRI will provide quantitative imaging biomarkers to predict or assess early treatment response in R/M head and neck ...