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.
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
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 group | Role | What they receive |
|---|---|---|
| Training set | The 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 set | The 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 set | The 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.
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.
- First posted3 Jan 2025
- Study start27 Nov 2024
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HNSCCStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zigong The Fourth People's Hospital
- Responsible party
- Principal investigator, xinwei Chen, First Affiliated Hospital of Chongqing Medical University
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
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-based Radiomics Predicts Occult LNM and Uncovers Immune Microenvironment of Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT06757530
- Acronym / sponsor ID
- 2024-Chenxin
- Conditions
- HNSCC
- Keywords
- Radiogenomics, Occult lymph node metastasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Collaborators
- Zigong The Fourth People's Hospital
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Training set | – | Diagnostic Test: AIThe 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. |
| internal test set | – | Diagnostic Test: AIThe internal validation set included approximately 150 patients, randomly selected from the training cohort. This set was used for model evaluation and tuning. |
| external test set | – | Diagnostic Test: AIThe 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients who received other treatments before surgery;
- CT images with significant artifacts;
- Patients with tumor recurrence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIUsing artificial intelligence models to distinguish between patients with lymph node metastasis and those without lymph node metastasis. | Diagnostic test | Training set, external test set, internal test set |
Primary outcome
AUC
Time frame: The 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.