Imaging Technique for Head and Neck Cancer-related Lymphedema

Overseen By The Ohio State Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Non-compliance, others

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

Compensation: Varies

Number of Visits: 6

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial investigates a new approach using a mobile three-dimensional (3D) scanning application for volumetric measurement of the head and neck region in patients with head and neck lymphedema. Lymphedema is the buildup of extra lymph fluid in tissues that causes swelling. Accurate volumetric measurements of swelling are crucial to the diagnosis of lymphedema and to monitoring response to therapy and disease progression over time. A mobile 3D surface scanning application may help doctors measure and analyze swelling in patients with head and neck lymphedema.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Imaging Technique for head and neck cancer-related lymphedema?

Imaging techniques like CT, MRI, and PET are crucial in managing head and neck cancer by accurately diagnosing and staging the disease, which helps tailor treatment plans and improve outcomes. These imaging methods can predict treatment success and guide further therapy decisions, suggesting their potential effectiveness in managing related conditions like lymphedema. ^{1 2 3 4 5}

Is the imaging technique for head and neck cancer-related lymphedema safe for humans?

The imaging techniques discussed, such as PET-CT, MRI, and SPECT/CT, are generally used in medical practice and considered safe, but specific safety data for lymphedema imaging is not detailed in the provided research. The terminated study on iron oxide nanoparticle MRI was due to an FDA warning, indicating potential safety concerns with that specific contrast agent. ^{6 7 8 9 10}

How does this imaging treatment for head and neck cancer-related lymphedema differ from other treatments?

This imaging treatment is unique because it uses advanced imaging techniques like MRI and PET to provide detailed information about the tumor's function and structure, which can help in planning more effective radiation therapy. Unlike traditional imaging methods, these techniques can better differentiate between tumor tissue and normal tissue, potentially improving treatment outcomes. ^{11 12 13 14 15}

Research Team

Roman Skoracki, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for individuals with clear thinking who can make informed decisions, have minimal or no facial hair, and suffer from swelling due to lymph fluid buildup in the head and neck area. People with health issues that could affect the study or a history of not following medical advice are not eligible.

Inclusion Criteria

You have very little or no hair on your face.

I have swelling in my head or neck due to a medical condition.

I am mentally capable of making my own health decisions.

Exclusion Criteria

Any health conditions or history of non-compliance that affect the study will preclude study participation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Pre-Surgery 3D Scanning

Participants undergo 3D scanning of the lower head and neck region over 90-120 seconds before surgery

1 day

1 visit (in-person)

Post-Surgery Monitoring

Participants undergo 3D scanning every 3 months for up to 1 year after surgery to monitor head and neck lymphedema

12 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Treatment Details

Interventions

• Imaging Technique

Trial Overview The trial is testing a new mobile app that uses 3D scanning to measure swelling in patients with head and neck lymphedema. This tool aims to improve how doctors diagnose lymphedema, track treatment responses, and monitor disease progression.

Participant Groups

Group I: Screening (3D scan) Experimental Treatment 1 Intervention

Patients undergo 3D scanning of lower head and neck region over 90-120 seconds before surgery and then every 3 months for up to 1 year after surgery.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Findings from Research

Hybrid PET-MR imaging shows significant promise in improving the imaging quality for head and neck cancers, which are complex and challenging to diagnose due to their anatomy.

Incorporating advanced MR imaging techniques with PET-MR could further enhance the diagnostic capabilities, aiding in better preoperative and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET-MR Imaging in Head and Neck. Lee, YZ., Ramalho, J., Kessler, B.[2017]

Advanced imaging techniques like CT, MRI, and PET scans are crucial in managing head and neck cancer, providing predictive insights about patient outcomes that go beyond traditional TNM classification.

Using pre-treatment imaging to customize radiotherapy plans can improve tumor control rates while minimizing damage to healthy tissues, and early post-treatment imaging helps determine the need for additional treatment or monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Head and neck cancer: how imaging predicts treatment outcome. Hermans, R.[2018]

Accurate staging and timely assessment using advanced imaging techniques like CT, MRI, and PET are crucial for developing effective treatment strategies in head-and-neck cancer patients.

Post-treatment imaging is essential for detecting potential recurrences and assessing tumor extent, which helps in deciding if salvage therapy is a viable option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging modalities in head-and-neck cancer patients. Sham, ME., Nishat, S.[2013]

Accurate imaging is crucial for staging head and neck cancer, which helps in planning effective treatments like radiation therapy and surgery.

Recent evidence highlights the importance of various imaging techniques, including ultrasound, CT, MRI, and PET-CT, in accurately assessing the disease stage and monitoring treatment response in patients with head and neck squamous cell cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modern Radiology in the Management of Head and Neck Cancer. Burkill, GJ., Evans, RM., Raman, VV., et al.[2018]

Dynamic contrast-enhanced MRI successfully distinguished between tumor and nontumor nodes in the cervical lymph nodes of 21 patients with squamous cell carcinoma, highlighting its potential as a diagnostic tool.

The study identified significant differences in contrast enhancement parameters between tumor and nontumor nodes, suggesting that dynamic imaging can effectively aid in the assessment of cervical lymph node involvement in head and neck cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges in dynamic contrast-enhanced MRI imaging of cervical lymph nodes to detect metastatic disease. Noworolski, SM., Fischbein, NJ., Kaplan, MJ., et al.[2019]

Post-treatment surveillance is crucial for head and neck cancer patients, particularly as HPV-positive cases rise, since early detection of recurrences can improve treatment success and reduce toxicity.

While PET-CT imaging shows promise as the most sensitive method for detecting recurrences, more research is needed to confirm its impact on patient outcomes, highlighting the need for tailored surveillance plans at healthcare institutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surveillance imaging following treatment of head and neck cancer. Zhao, X., Rao, S.[2019]

Recent studies indicate that advanced imaging techniques, especially functional MRI, can effectively assess treatment-related changes in head and neck cancer patients, such as muscle damage and conditions like lymphoedema and dysphagia.

These novel imaging methods show promise in predicting functional outcomes after chemoradiotherapy, potentially leading to improved management of side effects and better quality of life for survivors of head and neck cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in and applications of imaging and radiomics in head and neck cancer survivorship. Wishart, LR., Ward, EC., Galloway, G.[2023]

Lymph drainage mapping (LDM) using SPECT/CT was successfully performed in 54 out of 55 head and neck cancer patients, demonstrating a high feasibility rate of 98%.

In 20% of patients, contralateral lymph drainage was observed, particularly in T3 tumors, suggesting that selective unilateral elective neck irradiation could reduce unnecessary radiation exposure and improve quality of life for patients without contralateral drainage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SPECT/CT-guided lymph drainage mapping for the planning of unilateral elective nodal irradiation in head and neck squamous cell carcinoma. de Veij Mestdagh, PD., Jonker, MCJ., Vogel, WV., et al.[2022]

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]

The study involving 44 patients with head and neck squamous cell carcinoma demonstrated that using sentinel lymph node (SLN) mapping with SPECT/CT allows for a significant reduction in the elective nodal target volumes, which were found to be half the size compared to standard guidelines, without compromising tumor control.

Patients experienced reduced radiation-related toxicity, with significant decreases in the risk of xerostomia, dysphagia, and hypothyroidism, leading to improved quality of life, especially in those who received unilateral irradiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized Prophylactic Neck Irradiation in Patients with cN0 Head and Neck Cancer Based on Sentinel Lymph Node(s) Identification: Definitive Results of a Prospective Phase 1-2 Study. Longton, E., Lawson, G., Bihin, B., et al.[2021]

Head and neck squamous cell carcinoma is a good candidate for advanced medical imaging techniques in radiotherapy planning, as these tumors are often localized and can be effectively treated with targeted radiation.

Recent imaging advancements, such as MRI and PET, can improve the accuracy of tumor delineation and provide valuable physiological information, potentially leading to better treatment outcomes through optimized radiation dose delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced imaging applied to radiotherapy planning in head and neck cancer: a clinical review. Newbold, K., Partridge, M., Cook, G., et al.[2016]

Head and neck imaging is crucial for cancer management, aiding in planning, surgery, and radiotherapy, with different imaging techniques having specific advantages and limitations.

CT scans are the gold standard for imaging the pharyngolarynx, while MRI is preferred for the oral cavity and oropharynx, and ultrasound is effective for studying cervical lymph nodes, highlighting the importance of multimodal imaging in accurate diagnosis and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Imaging in head and neck cancers]. Iannessi, A., Ouvrier, MJ., Thariat, J., et al.[2014]

Recent trends in head and neck radiology emphasize the importance of obtaining detailed morphological information through advanced imaging techniques like thin-sliced CT and MRI.

There is a growing integration of functional and metabolic imaging methods, such as diffusion-weighted MRI and PET, alongside traditional anatomical imaging, which has significantly enhanced the diagnostic capabilities in oncological radiology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in head and neck radiology. Kösling, S.[2021]

Positron emission tomography (PET) offers a significant advantage in head and neck cancer imaging by allowing for whole-body scans, which can help detect synchronous tumors that other imaging methods may miss.

PET is particularly useful for identifying neck metastases when the primary tumor site is unknown, providing critical information that can improve staging and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of PET in Head and Neck Cancers. Özel, HE.[2020]

Modern imaging techniques like CT and MRI are crucial for accurately diagnosing and determining the extent of head and neck cancers, providing detailed information about how tumors interact with surrounding tissues.

Advanced imaging methods such as MRA, CTA, and PET enhance the ability to evaluate tumor blood supply and differentiate tumors from noncancerous tissues, improving treatment planning and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current imaging techniques for head and neck tumors. Weissman, JL., Akindele, R.[2005]

References

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

PET-MR Imaging in Head and Neck. [2017]

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

Head and neck cancer: how imaging predicts treatment outcome. [2018]

3. India pubmed.ncbi.nlm.nih.gov

Imaging modalities in head-and-neck cancer patients. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Modern Radiology in the Management of Head and Neck Cancer. [2018]

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

Challenges in dynamic contrast-enhanced MRI imaging of cervical lymph nodes to detect metastatic disease. [2019]

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

Surveillance imaging following treatment of head and neck cancer. [2019]

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

Advances in and applications of imaging and radiomics in head and neck cancer survivorship. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

SPECT/CT-guided lymph drainage mapping for the planning of unilateral elective nodal irradiation in head and neck squamous cell carcinoma. [2022]

9. England pubmed.ncbi.nlm.nih.gov

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

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

Individualized Prophylactic Neck Irradiation in Patients with cN0 Head and Neck Cancer Based on Sentinel Lymph Node(s) Identification: Definitive Results of a Prospective Phase 1-2 Study. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Advanced imaging applied to radiotherapy planning in head and neck cancer: a clinical review. [2016]

12. France pubmed.ncbi.nlm.nih.gov

[Imaging in head and neck cancers]. [2014]

13. Germany pubmed.ncbi.nlm.nih.gov

Trends in head and neck radiology. [2021]

14. Turkey pubmed.ncbi.nlm.nih.gov

Use of PET in Head and Neck Cancers. [2020]

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

Current imaging techniques for head and neck tumors. [2005]