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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment involving MRI and Biomarker Monitoring for Head and Neck Cancer?

Research shows that using MRI to monitor changes in tumor size and characteristics during treatment can help predict how well head and neck cancer patients respond to therapy. This approach helps doctors tailor treatments more effectively to improve outcomes. ^{1 2 3 4 5}

Is MRI safe for monitoring head and neck cancer?

The studies reviewed do not provide specific safety data for MRI in head and neck cancer, but MRI is generally considered safe for human use. However, one study involving ferumoxytol, a contrast agent for MRI, was terminated due to an FDA black box warning, indicating potential safety concerns with that specific agent. ^{6 7 8 9 10}

How does MRI and biomarker monitoring differ from other treatments for head and neck cancer?

This treatment is unique because it uses advanced MRI techniques to monitor changes in the tumor during radiation therapy, helping to predict how well the cancer is responding to treatment. Unlike traditional methods, it focuses on imaging biomarkers to provide a more personalized approach to managing head and neck cancer. ^{1 2 3 11 12}

What is the purpose of this trial?

This trial aims to find ways to predict how tumors in the head and neck respond to treatment. The goal is to improve understanding of tumor responses and plan better treatments.

Research Team

Clifton D. Fuller

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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 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]

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 (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]

References

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

Longitudinal diffusion and volumetric kinetics of head and neck cancer magnetic resonance on a 1.5T MR-Linear accelerator hybrid system: A prospective R-IDEAL Stage 2a imaging biomarker characterization/ pre-qualification study. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Longitudinal diffusion and volumetric kinetics of head and neck cancer magnetic resonance on a 1.5 T MR-linear accelerator hybrid system: A prospective R-IDEAL stage 2a imaging biomarker characterization/pre-qualification study. [2023]

3. 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]

4. Germany pubmed.ncbi.nlm.nih.gov

Monitoring of tumor oxygenation changes in head-and-neck carcinoma patients breathing a hyperoxic hypercapnic gas mixture with a noninvasive MRI technique. [2021]

5. United States 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. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Data from a terminated study on iron oxide nanoparticle magnetic resonance imaging for head and neck tumors. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Acquisition repeatability of MRI radiomics features in the head and neck: a dual-3D-sequence multi-scan study. [2022]

8. Ireland 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. [2023]

9. Ireland pubmed.ncbi.nlm.nih.gov

Reproducibility of diffusion-weighted magnetic resonance imaging in head and neck cancer assessed on a 1.5 T MR-Linac and comparison to parallel measurements on a 3 T diagnostic scanner. [2023]

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

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

11. 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]

12. England pubmed.ncbi.nlm.nih.gov

Early detection treatment response for head and neck carcinomas using intravoxel incoherent motion-magnetic resonance imaging: a meta-analysis. [2022]