AzTrials
AzTrials

HNSCCNCT06757530

Radiomics Model for Assessing Lymph Node Status in cN0 Patients withHNSCC

An observational study of HNSCC, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
HNSCC
What is being tested?
AI
How many people
700 participants
Where
1 siteChina
Study dates
27 Nov 2024to 15 Apr 2025
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients with pathologically confirmed laryngeal carcinoma between January 2016 and December 2024 from three hospitals were collected and were divided into different test groups.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site
  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing

Other trials in China

About this study

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

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.

Read the 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.

Conditions
HNSCC
Being tested
AI
Keywords
Radiogenomics, Occult lymph node metastasis
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AIDiagnostic test

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

Study groups in NCT06757530
Study groupRoleWhat they receive
Training setThe training set comprised approximately 500 cN0 patients diagnosed with head and neck squamous cell carcinoma (HNSCC), including approximately 150 patients with lymph node metastasis and approximately 350 patients without metastasis. All patients underwent preoperative contrast-enhanced CT scans.
Receives: Diagnostic Test: AI
internal test setThe internal validation set included approximately 150 patients, randomly selected from the training cohort. This set was used for model evaluation and tuning.
Receives: Diagnostic Test: AI
external test setThe external validation set consisted of approximately 200 patients with HNSCC. These patients were enrolled from other centers, and their data included preoperative contrast-enhanced CT images. This independent dataset was used to assess the generalizability of the radiomics model.
Receives: Diagnostic Test: AI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC

    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.

    Measured: The prediction results can be obtained immediately after the model completes processing.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2025
  2. Study start27 Nov 2024
  3. Primary completion15 Apr 2025
  4. Study completion15 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
700 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06757530
Sponsor's protocol ID
2024-Chenxin
Status last verified
May 2025
First submitted
27 Dec 2024
Last updated
28 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of HNSCC, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC (time frame: The prediction results can be obtained immediately after the model completes processing.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in