80 Participants Needed

Imaging Technique for Head and Neck Cancer-related Lymphedema

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Overseen ByThe Ohio State Comprehensive Cancer Center
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.678910

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.1112131415

Who Is on the Research Team?

RS

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?
1Treatment groups
Experimental Treatment
Group I: Screening (3D scan)Experimental Treatment1 Intervention

Find a Clinic Near You

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

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

Citations

PET-MR Imaging in Head and Neck. [2017]
Head and neck cancer: how imaging predicts treatment outcome. [2018]
Imaging modalities in head-and-neck cancer patients. [2013]
Modern Radiology in the Management of Head and Neck Cancer. [2018]
Challenges in dynamic contrast-enhanced MRI imaging of cervical lymph nodes to detect metastatic disease. [2019]
Surveillance imaging following treatment of head and neck cancer. [2019]
Advances in and applications of imaging and radiomics in head and neck cancer survivorship. [2023]
SPECT/CT-guided lymph drainage mapping for the planning of unilateral elective nodal irradiation in head and neck squamous cell carcinoma. [2022]
Data from a terminated study on iron oxide nanoparticle magnetic resonance imaging for head and neck tumors. [2021]
10.United Statespubmed.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]
Advanced imaging applied to radiotherapy planning in head and neck cancer: a clinical review. [2016]
[Imaging in head and neck cancers]. [2014]
Trends in head and neck radiology. [2021]
Use of PET in Head and Neck Cancers. [2020]
15.United Statespubmed.ncbi.nlm.nih.gov
Current imaging techniques for head and neck tumors. [2005]
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