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Radiomics Model for Assessing Lymph Node Status in cN0 Patients withHNSCC

CT-based Radiomics Predicts Occult LNM and Uncovers Immune Microenvironment of Head and Neck Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06757530
Enrollment
700
Registered
2025-01-03
Start date
2024-11-27
Completion date
2025-04-15
Last updated
2025-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HNSCC

Keywords

Radiogenomics, Occult lymph node metastasis

Brief summary

Occult lymph node metastasis (LNM) remains one of the most critical and challenging aspects of managing head and neck squamous cell carcinoma (HNSCC). Defined as the presence of metastatic disease in lymph nodes that are clinically undetectable through routine imaging or physical examination, occult LNM has profound implications for treatment planning, prognosis, and overall patient management. In HNSCC, accurate detection and prediction of occult LNM are crucial as they significantly influence decisions regarding the extent of neck dissection, the need for adjuvant therapies, and the overall therapeutic strategy. Undiagnosed or underestimated LNM can result in inadequate treatment, increasing the risk of locoregional recurrence and poor survival outcomes.

Detailed description

Occult lymph node metastasis (LNM) remains one of the most critical and challenging aspects of managing head and neck squamous cell carcinoma (HNSCC). Defined as the presence of metastatic disease in lymph nodes that are clinically undetectable through routine imaging or physical examination, occult LNM has profound implications for treatment planning, prognosis, and overall patient management. In HNSCC, accurate detection and prediction of occult LNM are crucial as they significantly influence decisions regarding the extent of neck dissection, the need for adjuvant therapies, and the overall therapeutic strategy. Undiagnosed or underestimated LNM can result in inadequate treatment, increasing the risk of locoregional recurrence and poor survival outcomes. The complex biology of HNSCC adds to the challenge of predicting occult LNM. These tumors are often characterized by substantial heterogeneity in their microenvironment, comprising a mix of tumor cells, immune infiltrates, stromal components, and vasculature. This heterogeneity plays a pivotal role in determining the metastatic potential of the primary tumor and its interaction with the surrounding lymphatic system. Traditional imaging modalities such as CT, MRI, and PET/CT have limitations in accurately identifying microscopic metastases, leading to the ongoing search for more sensitive and specific predictive tools. Recent advances in radiomics have opened new avenues for addressing this challenge. Radiomics, an emerging field that extracts high-dimensional data from medical imaging, allows for the quantitative analysis of tumor characteristics beyond what is visible to the naked eye. By converting imaging data into a rich repository of features that reflect tumor phenotype, radiomics has the potential to identify subtle patterns associated with metastatic behavior. Accurate prediction of occult LNM also holds critical prognostic value. Patients with undetected LNM often face a worse prognosis due to delayed or insufficient treatment. Conversely, unnecessary prophylactic neck dissection in patients without metastasis can lead to overtreatment, increased surgical morbidity, and diminished quality of life. Therefore, predictive models that can stratify patients based on their risk of occult LNM are essential for personalizing treatment plans, reducing unnecessary interventions, and improving patient outcomes. In this context, the integration of radiomics with multi-omics data, including transcriptomics and single-cell RNA sequencing, represents a transformative approach. This integrative strategy not only enhances the predictive power of radiomics models but also provides a window into the biological processes underlying tumor behavior. By linking imaging-derived features to molecular and cellular pathways, such approaches can help bridge the gap between imaging phenotypes and the complex biology of metastasis. In summary, occult LNM poses a formidable challenge in the clinical management of HNSCC, with significant implications for treatment and prognosis. The advent of advanced radiomics techniques, particularly habitat radiomics, offers a promising avenue for improving the accuracy of LNM prediction. By unraveling the interplay between tumor heterogeneity, microenvironmental dynamics, and metastatic potential, these approaches pave the way for more precise and personalized management of HNSCC patients.

Interventions

DIAGNOSTIC_TESTAI

Using artificial intelligence models to distinguish between patients with lymph node metastasis and those without lymph node metastasis.

Sponsors

Zigong The Fourth People's Hospital
CollaboratorOTHER
First Affiliated Hospital of Chongqing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

Inclusion criteria

1. Availability of complete clinical data; 2. Diagnosis of laryngeal squamous cell carcinoma confirmed by surgery or biopsy; 3. CT contrast-enhanced examination performed within two weeks prior to surgery. 4. All patients underwent neck lymph node dissection surgery.

Exclusion criteria

1. Patients who received other treatments before surgery; 2. CT images with significant artifacts; 3. Patients with tumor recurrence.

Design outcomes

Primary

MeasureTime frameDescription
AUCThe prediction results can be obtained immediately after the model completes processing.AUC (Area Under the Curve) is a performance metric used in classification tasks to evaluate the ability of a model to distinguish between classes. Specifically, it measures the area under the Receiver Operating Characteristic (ROC) curve, which plots the true positive rate (sensitivity) against the false positive rate (1-specificity) at various threshold settings.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026