Imaging Technique for Head and Neck Cancer-related Lymphedema
Recruiting in Palo Alto (17 mi)
Overseen byRoman Skoracki, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ohio State University Comprehensive Cancer Center
Disqualifiers: Non-compliance, others
No Placebo Group
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.12345
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.678910
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.1112131415
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
Trial 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 (3D Surface Scanning)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Screening (3D scan)Experimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ohio State University Comprehensive Cancer CenterColumbus, OH
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Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
References
PET-MR Imaging in Head and Neck. [2017]Head and neck cancers are a diverse group of cancers with high morbidity and mortality within an area of complex anatomy. High-quality anatomic and functional imaging is essential for preoperative, chemotherapeutic, and radiotherapy planning. Early studies show that hybrid PET-MR imaging offers great potential for improving the imaging of head and neck cancers. Furthermore, advanced MR imaging techniques may also be incorporated to further enhance the diagnostic value of the combined modality.
Head and neck cancer: how imaging predicts treatment outcome. [2018]Sophisticated imaging methods, such as computed tomography, magnetic resonance imaging and positron emission tomography, play an increasingly important role in the management of head and neck cancer. Pretreatment imaging findings have predictive value for patient outcome, independently from the currently used TNM classification, and may be used to tailor treatment to the individual patient. Based on per-treatment imaging, individualised replanning during radiotherapy may ameliorate tumour control rates and reduce toxic effects to normal tissues. Early posttreatment imaging studies contain important prognostic information, and allow selection of patients for further treatment or watchful waiting.
Imaging modalities in head-and-neck cancer patients. [2013]Accurate staging and timely assessment is critical in head-and-neck cancer patients for formulating the appropriate treatment strategy. Therefore, optimizing pretreatment imaging for diagnosis is of great importance. Computerized tomography (CT), introduced in the early 70s, followed by magnetic resonance imaging (MRI) and positron emission tomography (PET), refinements in ultrasonography (USG), advances in nuclear medicine, and applications such as sentinel node lymphoscintigraphy have greatly added to diagnostic accuracy. Post-treatment CT or MRI is of value when a recurrent tumor is suspected. It can confirm the presence of such a lesion and determine its extent. This is important information for determining the possibility of salvage therapy.
Modern Radiology in the Management of Head and Neck Cancer. [2018]The accurate staging of head and neck cancer is vital to direct appropriate management strategies and to deliver the best radiation therapy and surgery. Initial challenges in head and neck cancer imaging include determination of T- and N-stage, stage migration with detection of metastatic disease and identification of primary disease in the patient presenting with nodal metastases. In follow-up, imaging has an important role in assessing patients who may require salvage surgery after radiotherapy and assessing clinical change that may represent either residual/recurrent disease or radiation effects. This overview gathers recent evidence on the optimal use of currently readily available imaging modalities (ultrasound, computed tomography, magnetic resonance imaging and positron emission tomography-computed tomography) in the context of head and neck squamous cell cancers.
Challenges in dynamic contrast-enhanced MRI imaging of cervical lymph nodes to detect metastatic disease. [2019]To identify and overcome challenges in using dynamic contrast-enhanced magnetic resonance imaging (MRI) to distinguish tumor from nontumor in the cervical lymph nodes of patients with squamous cell carcinoma of the head and neck.
Surveillance imaging following treatment of head and neck cancer. [2019]Post-treatment surveillance is an important component in the treatment of head and neck cancers, especially as the proportion of human papilloma virus-positive cancers increases. Early detection of recurrences or second malignancies can increase success and minimize the toxicity of salvage treatment. Unfortunately, there are no consensus guidelines on the frequency and modality of post-treatment imaging. Computed tomography, ultrasound, magnetic resonance imaging and positron emission tomography-computed tomography (PET-CT) all have unique advantages and disadvantages when used as surveillance imaging. There is evidence that PET-CT may be the most sensitive of these modalities, but further research is needed to show an improvement in patient outcomes. Institutions will benefit most from a surveillance plan that is consistent and tailored to the individualized needs of their patients. This review focuses on the available evidence for different imaging modalities and general guidelines for developing an institution-specific practice pattern.
Advances in and applications of imaging and radiomics in head and neck cancer survivorship. [2023]Radiological imaging is an essential component of head/neck cancer (HNC) care. Advances in imaging modalities (including CT, PET, MRI and ultrasound) and analysis have enhanced our understanding of tumour characteristics and prognosis. However, the application of these methods to evaluate treatment-related toxicities and functional burden is still emerging. This review showcases recent literature applying advanced imaging and radiomics to the assessment and management of sequelae following chemoradiotherapy for HNC.
SPECT/CT-guided lymph drainage mapping for the planning of unilateral elective nodal irradiation in head and neck squamous cell carcinoma. [2022]To investigate the feasibility of lymph drainage mapping (LDM) using SPECT/CT to help select head and neck cancer (HNSCC) patients for unilateral elective neck irradiation (ENI). Patients with lateralized HNSCC treated with radiotherapy routinely undergo bilateral ENI, despite the incidence of contralateral regional failure being relatively low even after unilateral ENI. We hypothesized that patients with a lateralized tumor without visible lymph drainage to the contralateral neck have an extremely low risk of contralateral involved nodes. Excluding the contralateral neck from elective irradiation will reduce radiation-induced toxicity and improve quality-of-life.
Data from a terminated study on iron oxide nanoparticle magnetic resonance imaging for head and neck tumors. [2021]Node positive head and neck squamous cell carcinomas (HNSCCs) patients exhibit worse outcomes in terms of regional neck control, risk for distant metastases and overall survival. Smaller non-palpable lymph nodes may be inflammatory or may harbor clinically occult metastases, a characterization that can be challenging to make using routine imaging modalities. Ferumoxytol has been previously investigated as an intra-tumoral contrast agent for magnetic resonance imaging (MRI) for intracranial malignancies and lymph node agent in prostate cancer. Hence, our group was motivated to carry out a prospective feasibility study to assess the feasibility of ferumoxytol dynamic contrast enhanced (DCE)-weighted MRI relative to that of gadolinium-based DCE-MRI for nodal and primary tumor imaging in patients with biopsy-proven node-positive HNSCC or melanoma. Although this institutional review board (IRB)-approved study was prematurely terminated because of an FDA black box warning, the investigators sought to curate and publish this unique dataset of matched clinical, and anatomical and DCE MRI data for the enrolled five patients to be available for scientists interested in molecular imaging.
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]This prospective, nonrandomized, interventional phase 1-2 study investigated the individualization of elective node irradiation in clinically N0 head and neck squamous cell carcinoma by sentinel lymph node (SLN) mapping with single-photon emission computed tomography/computed tomography (SPECT/CT) and its impact on tumor control and radiation-related toxicity.
Advanced imaging applied to radiotherapy planning in head and neck cancer: a clinical review. [2016]Head and neck squamous cell carcinoma represents an ideal model to investigate the application of recent advances in medical imaging to radiotherapy planning. Tumours usually remain localized, and are potentially curable with local radiation. The steep radiation dose-response relationships support the strategies of radiation dose escalation to increase local control. Two-dimensional simulator-based planning and CT planning have significant drawbacks in terms of accurate target volume definition. MRI has enhanced soft tissue delineation, but has to be fused with CT to allow dose calculation. Functional imaging using dynamic contrast enhanced CT or MRI sequences may allow improved knowledge of tumour function. Positron emission tomography (PET) may allow further physiological information to be determined. This review summarizes the current techniques in clinical development in this area.
[Imaging in head and neck cancers]. [2014]The head and neck imaging plays a central role at all stages of the management of cancer. Indeed, the image allows the oncology planning, surgery and radiotherapy. It is a multimodal imaging and the advantages and limitations of each technique must be known. Good knowledge of cervical anatomy is a necessary prerequisite for communication with the multidisciplinary committee. The computerised tomodensitometry is the gold standard for the pharyngolarynx. The MRI is the modality of choice for the oral cavity, oropharynx and nasopharynx. Ultrasound allows a comprehensive study of cervical lymph nodes. Functional imaging and nuclear medicine are still under evaluation. However, the literature already allows establishing their usefulness where morphological imaging is limited. The diagnosis of subclinical metastatic lymph nodes, the differentiation between recurrence and post-treatment modifications, monitoring chemotherapy and radiation therapy planning are indications for which new imaging techniques are invaluable.
Trends in head and neck radiology. [2021]Trends in clinical research of head and neck radiology are well described within four articles published in the European Radiology in the last 2 years. One constant top issue is to gain more, better or new morphological information by so-called "conventional" methods (CT, MRI) with thin-sliced imaging including special reconstructions. The addition of functional or metabolic methods (e.g. diffusion-weighted MRI, dynamic contrast-enhanced MRI, positron emission tomography) to anatomical imaging is a further general trend in oncological radiology over the last few years and has been invaluable in head and neck radiology.
Use of PET in Head and Neck Cancers. [2020]Head and neck cancer imaging is especially necessary for staging. Computed tomography and magnetic resonance imaging are the techniques frequently used for this purpose. These methods are valuable for displaying detailed anatomical structures; however, they may be inadequate for making the distinction between recurrence, residual tumor, fibrosis, and normal tissues with an altered anatomy after treatments such as surgery, radiotherapy, and chemotherapy and for the detection of metastases. From this point, positron emission tomography may be a promising imaging method. Scanning the entire body with a single method is an important advantage of positron emission tomography. It may be useful in the detection of synchronous tumors, which are a serious problem in head and neck cancers. Positron emission tomography may provide additional contribution for neck metastases, where the primary site is unknown and is undetectable by other imaging techniques.
Current imaging techniques for head and neck tumors. [2005]Modern head and neck imaging has led to advances in both the diagnosis and treatment of head and neck cancers. Both computed tomography (CT) and magnetic resonance imaging (MRI) studies provide important information about the location and extent of neoplasm, particularly with respect to the interface of tumor with bone, fat, muscles and other soft tissues, air, blood vessels, dura, and brain. Conventional angiography can be used to assess tumor blood supply and vascularity and to perform therapeutic embolization. Magnetic resonance angiography (MRA) and CT angiography (CTA) are new tools for the noninvasive evaluation of blood vessels. Positron emission tomography (PET) shows promise for differentiating tumor from scar, edema, and other nonneoplastic soft tissues.