Detection and Biopsy Guidance of Nasopharyngeal Carcinoma Based on Artificial Intelligence and Endoscopic Images

Study Overview
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Brief Summary
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Due to the occult anatomic location of the nasopharynx and frequent presence of adenoid hyperplasia, the positive rate for nasopharyngeal carcinoma identification during biopsy is low, thus leading to delayed or missed diagnosis for nasopharyngeal carcinoma upon initial attempt. Here, we aimed to develop an artificial intelligence tool to detect nasopharyngeal malignancies and guide biopsy under endoscopic examination based on deep learning.

Detailed Description
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Due to the occult anatomic location of the nasopharynx and frequent presence of adenoid hyperplasia, the positive rate for nasopharyngeal carcinoma identification during biopsy is low, thus leading to delayed or missed diagnosis for nasopharyngeal carcinoma upon initial attempt. Here, we aimed to develop an artificial intelligence tool to detect nasopharyngeal malignancies and guide biopsy under endoscopic examination based on deep learning.

Official Title
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Detection and Biopsy Guidance of Nasopharyngeal Carcinoma Based on Artificial Intelligence and Endoscopic Images：a Multi-center Prospective Study

Conditions
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Nasopharyngeal Carcinoma, Image-Guided Biopsy

Intervention / Treatment
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* Diagnostic Test: Nasopharyngeal Endoscopy image-guided Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient was found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy and the clinicans considered it necessary to perform an biopsy. Hemilateral lesion with limited size. Exclusion Criteria: Patients with nasopharyngeal cancer, oropharyngeal cancer, hypopharyngeal cancer, etc. who have already been treated.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sun Yat-Sen University Cancer Center<br>The participant who is found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy in Sun Yat-Sen University Cancer Center. The physicians in Sun Yat-Sen University Cancer Center consider it necessary to perform an endoscopic image-guided biopsy. | Diagnostic Test: Nasopharyngeal Endoscopy image-guided Biopsy<br>* For each participant presenting with a suspicious nasopharyngeal lesion, the attending physician will assess the lesion and determine the appropriate biopsy approach. The physician may decide on multiple biopsies from the lesion area, including one sample from within the lesion itself, another from 5-8 mm outside the lesion, and a third from 8-10 mm beyond the lesion. Alternatively, a single biopsy may be deemed sufficient based on the clinical judgment. Each of these specimens will undergo pathological examination to confirm whether they are carcinomatous or non-carcinomatous.<br>|
| Guangdong Provincial People's Hospital<br>The participant who is found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy in Guangdong Provincial People's Hospital. The physicians in Guangdong Provincial People's Hospital consider it necessary to perform an endoscopic image-guided biopsy. | Diagnostic Test: Nasopharyngeal Endoscopy image-guided Biopsy<br>* For each participant presenting with a suspicious nasopharyngeal lesion, the attending physician will assess the lesion and determine the appropriate biopsy approach. The physician may decide on multiple biopsies from the lesion area, including one sample from within the lesion itself, another from 5-8 mm outside the lesion, and a third from 8-10 mm beyond the lesion. Alternatively, a single biopsy may be deemed sufficient based on the clinical judgment. Each of these specimens will undergo pathological examination to confirm whether they are carcinomatous or non-carcinomatous.<br>|
| Nanfang Hospital, Southern Medical University<br>The participant who is found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy in Nanfang Hospital. The physicians in Nanfang Hospital consider it necessary to perform an endoscopic image-guided biopsy. | Diagnostic Test: Nasopharyngeal Endoscopy image-guided Biopsy<br>* For each participant presenting with a suspicious nasopharyngeal lesion, the attending physician will assess the lesion and determine the appropriate biopsy approach. The physician may decide on multiple biopsies from the lesion area, including one sample from within the lesion itself, another from 5-8 mm outside the lesion, and a third from 8-10 mm beyond the lesion. Alternatively, a single biopsy may be deemed sufficient based on the clinical judgment. Each of these specimens will undergo pathological examination to confirm whether they are carcinomatous or non-carcinomatous.<br>|
| Fujian Provincial Cancer Hospital<br>The participant who is found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy in Fujian Provincial Cancer Hospital. The physicians in Fujian Provincial Cancer Hospital consider it necessary to perform an endoscopic image-guided biopsy. | Diagnostic Test: Nasopharyngeal Endoscopy image-guided Biopsy<br>* For each participant presenting with a suspicious nasopharyngeal lesion, the attending physician will assess the lesion and determine the appropriate biopsy approach. The physician may decide on multiple biopsies from the lesion area, including one sample from within the lesion itself, another from 5-8 mm outside the lesion, and a third from 8-10 mm beyond the lesion. Alternatively, a single biopsy may be deemed sufficient based on the clinical judgment. Each of these specimens will undergo pathological examination to confirm whether they are carcinomatous or non-carcinomatous.<br>|
| Hainan Provincial People's Hospital<br>The participant who is found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy in Hainan Provincial People's Hospital. The physicians in Hainan Provincial People's Hospital consider it necessary to perform an endoscopic image-guided biopsy. | Diagnostic Test: Nasopharyngeal Endoscopy image-guided Biopsy<br>* For each participant presenting with a suspicious nasopharyngeal lesion, the attending physician will assess the lesion and determine the appropriate biopsy approach. The physician may decide on multiple biopsies from the lesion area, including one sample from within the lesion itself, another from 5-8 mm outside the lesion, and a third from 8-10 mm beyond the lesion. Alternatively, a single biopsy may be deemed sufficient based on the clinical judgment. Each of these specimens will undergo pathological examination to confirm whether they are carcinomatous or non-carcinomatous.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aera under the receiver operating characteristic curve (AUC) | AUC of an deep learning-based model in discriminating nasopharyngeal carcinoma from bengin lesion. | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuray | The agreement between the deep learning-based model and the histopathological diagnosis of the three biopsy specimens (inside the lesion, 5-8 mm outside the lesion, and 8-10 mm outside the lesion). | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artificial Intelligence, Classification, Nasopharyngeal Carcinoma, Nasopharyngoscope, Image-Guided Biopsy