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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05202626
• Other study ID #: CASMI002
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: June 28, 2025

Study information

• Verified date: October 2023
• Source: Chinese Academy of Sciences
• Contact: Di Dong, Ph.D
• Phone: +86 010-82618465
• Email: di.dong[@]ia.ac.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 28, 2025
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Image-Guided Biopsy
• Nasopharyngeal Carcinoma

Intervention

Diagnostic Test:
• Nasopharyngeal Endoscopy image-guided Biopsy
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.

Locations

Country	Name	City	State
China	Fujian Provincial Cancer Hospital	Fuzhou	Fujian
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	Hainan Provincial People's Hospital	Haikou	Hainan

Sponsors (6)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	Fujian Cancer Hospital, Guangdong Provincial People's Hospital, Hainan People's Hospital, Nanfang Hospital, Southern Medical University, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

Li C, Jing B, Ke L, Li B, Xia W, He C, Qian C, Zhao C, Mai H, Chen M, Cao K, Mo H, Guo L, Chen Q, Tang L, Qiu W, Yu Y, Liang H, Huang X, Liu G, Li W, Wang L, Sun R, Zou X, Guo S, Huang P, Luo D, Qiu F, Wu Y, Hua Y, Liu K, Lv S, Miao J, Xiang Y, Sun Y, Guo — View Citation

Zwakenberg MA, Halmos GB, Wedman J, van der Laan BFAM, Plaat BEC. Evaluating Laryngopharyngeal Tumor Extension Using Narrow Band Imaging Versus Conventional White Light Imaging. Laryngoscope. 2021 Jul;131(7):E2222-E2231. doi: 10.1002/lary.29361. Epub 2021 Jan 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Statistical significance	Statistical significance (P value) of DFS (time from diagnosis to disease progression or death from any cause) in nasopharyngeal carcinoma patients between high-risk and low-risk group identified by deep learning-based model.	Three years
Primary	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	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