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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to measure swelling in patients with head and neck lymphedema using a mobile 3D scanning app. Lymphedema causes swelling from fluid buildup, making accurate measurement crucial for treatment and progress tracking. The trial uses the app to scan the head and neck area before surgery and every three months for up to a year afterward. It suits individuals with head and neck lymphedema who have minimal facial hair and can make informed decisions. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future lymphedema care.

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 prior data suggests that this imaging technique is safe for measuring head and neck lymphedema?

Studies have shown that imaging techniques such as PET-CT and MRI are common in medical practice and generally considered safe. However, specific safety information for the mobile 3D scanning app is not detailed in the sources. Since this trial is in the "Not Applicable" phase, it primarily tests the technology rather than a new drug or invasive procedure. This phase usually indicates that the treatment is likely safe because it involves non-invasive scanning. Therefore, the mobile 3D scanning is expected to be well-tolerated by patients, with minimal risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on a new imaging technique for managing head and neck cancer-related lymphedema. Unlike traditional methods that might rely on physical examination or less detailed imaging, this technique uses a 3D scan to provide a comprehensive view of the affected area. This detailed imaging is done quickly, in just 90-120 seconds, and can be repeated every three months to monitor changes over time. The hope is that this approach will offer more precise information, potentially leading to better management of lymphedema and improved patient outcomes.

What evidence suggests that this imaging technique is effective for measuring head and neck lymphedema?

Research has shown that using 3D imaging to measure head and neck lymphedema (swelling from lymph fluid buildup) is a new and promising method. Although this technique hasn't been widely studied yet, early results suggest that 3D scanning can help doctors accurately track swelling over time. This is important because knowing the exact amount of swelling aids in diagnosing lymphedema and assessing treatment effectiveness. In this trial, participants will undergo 3D scanning of the lower head and neck region before surgery and then every 3 months for up to 1 year after surgery. The mobile 3D scanning app could become a valuable tool for providing detailed and reliable information to better manage and treat head and neck lymphedema. ^{2 4 5 6 7}

Who Is on the Research Team?

Roman Skoracki, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

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The Future of Head and Neck Lymphedema Assessment CONCLUSIONS: Use of 3D imaging for volume measurement in head and neck lymphedema has not been previously studied. Our study demonstrates that ...

2. withpower.com withpower.com/trial/phase-head-and-neck-neoplasms-2-2022-bf76d

Imaging Technique for Head and Neck Cancer-related ... This trial investigates a new approach using a mobile three-dimensional (3D) scanning application for volumetric measurement of the head and neck region in ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1368837525005007

Head and neck lymphedema after radiotherapy This study aimed to determine (i) the prevalence of external HNL, (ii) changes in HNL over a nine-month period post-treatment, and (iii) factors associated with ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-08318

Mobile 3D Scan for Volumetric Measurement of the Head ... A mobile 3D surface scanning application may help doctors measure and analyze swelling in patients with head and neck lymphedema. Eligibility Criteria ...

5. liebertpub.com liebertpub.com/doi/full/10.1089/lrb.2021.0100

Assessment of Measures of Head and Neck Lymphedema ... Purpose: Head and neck lymphedema is a common condition following head and neck cancer (HNC) treatment, with substantial functional morbidity.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05243069

Head and Neck Cancer Patient Symptom and Oncologic ... A mobile 3D surface scanning application may help doctors measure and analyze swelling in patients with head and neck lymphedema. Detailed Description. PRIMARY ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10915511/

Determining risk and predictors of head and neck cancer ... At 180 days, removing 0–25, 26–50, and > 50 lymph nodes increased external lymphedema risk to 72.1 %, 95.6 %, and 57.7 % respectively (p = 0.01) ...