Clinical trial · Observational
Development and Validation of a Deep Learning Model to Predict Distant Metastases in Nasopharyngeal Carcinoma Using Whole Slide Imaging and MRI
Development and Multicenter Validation of a Deep Learning Model Based on Whole Slide Imaging and Magnetic Resonance Imaging of the Nasopharynx and Lymph Nodes to Predict Distant Metastases at Diagnosis in Nasopharyngeal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
An AI model was developed to predict the likelihood of distant metastasis in patients with nasopharyngeal cancer based on pathology slides and MRI scans of the primary tumor. The model was validated using data from multiple centers. It was then applied to patients with advanced stages who were recommended to undergo PET/CT scans based on the NCCN or CSCO guidelines. This AI model can accurately screen patients with high risk of distant metastasis at the time of initial diagnosis to receive PET/CT, avoid excessive examination of patients with low risk of distant metastasis, save medical resources and reduce the economic burden on patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Distant Metastasis | — | UNRESOLVED | — |
| Nasopharyngeal Cancinoma (NPC) | Nasopharyngeal Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Prospective Validation Cohort
- description
- Prospective patient enrollment to validate the diagnostic efficacy of the AI model
Primary outcomes (1)
- measure
- Negative predictive value
- timeFrame
- through study completion, an average of 2 year
- description
- NPV measures the proportion of predicted negative cases that are actually negative. It tells us how reliable the model is when it predicts a negative outcome.
Secondary outcomes (1)
- measure
- Sensitivity, specificity, and positive predictive value
- timeFrame
- through study completion, an average of 2 year
- description
- Sensitivity, specificity, and positive predictive value of AI in predicting distant metastasis at the threshold corresponding to a negative predictive value of 95%.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: A. The primary lesion was pathologically confirmed as nasopharyngeal carcinoma (WHO classification is I, II and III); B. The stage was T3-4 or N2-3, and the nasopharynx + neck MRI plain scan and enhanced scan were performed to confirm the nasopharyngeal and cervical lymph node lesions, and PET/CT or conventional examination (chest CT plain scan + enhanced scan, upper abdominal CT or MRI plain scan + enhanced scan or abdominal color Doppler ultrasound or ultrasound angiography, and whole body bone imaging) was performed to screen for distant metastases. Exclusion Criteria: Previous history of other malignant tumors (such as other head and neck squamous cell carcinomas, thyroid cancer, breast cancer, esophageal cancer, etc.).
References
Publications (8)
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- BACKGROUNDQiang M, Li C, Sun Y, Sun Y, Ke L, Xie C, Zhang T, Zou Y, Qiu W, Gao M, Li Y, Li X, Zhan Z, Liu K, Chen X, Liang C, Chen Q, Mai H, Xie G, Guo X, Lv X. A Prognostic Predictive System Based on Deep Learning for Locoregionally Advanced Nasopharyngeal Carcinoma. J Natl Cancer Inst. 2021 May 4;113(5):606-615. doi: 10.1093/jnci/djaa149. PMID 32970812
- BACKGROUNDLin L, Dou Q, Jin YM, Zhou GQ, Tang YQ, Chen WL, Su BA, Liu F, Tao CJ, Jiang N, Li JY, Tang LL, Xie CM, Huang SM, Ma J, Heng PA, Wee JTS, Chua MLK, Chen H, Sun Y. Deep Learning for Automated Contouring of Primary Tumor Volumes by MRI for Nasopharyngeal Carcinoma. Radiology. 2019 Jun;291(3):677-686. doi: 10.1148/radiol.2019182012. Epub 2019 Mar 26. PMID 30912722
- BACKGROUNDOuYang PY, Zhang BY, Guo JG, Liu JN, Li J, Peng QH, Yang SS, He Y, Liu ZQ, Zhao YN, Li A, Wu YS, Hu XF, Chen C, Han F, You KY, Xie FY. Deep learning-based precise prediction and early detection of radiation-induced temporal lobe injury for nasopharyngeal carcinoma. EClinicalMedicine. 2023 Apr 4;58:101930. doi: 10.1016/j.eclinm.2023.101930. eCollection 2023 Apr. PMID 37090437
- BACKGROUNDOuYang PY, He Y, Guo JG, Liu JN, Wang ZL, Li A, Li J, Yang SS, Zhang X, Fan W, Wu YS, Liu ZQ, Zhang BY, Zhao YN, Gao MY, Zhang WJ, Xie CM, Xie FY. Artificial intelligence aided precise detection of local recurrence on MRI for nasopharyngeal carcinoma: a multicenter cohort study. EClinicalMedicine. 2023 Aug 30;63:102202. doi: 10.1016/j.eclinm.2023.102202. eCollection 2023 Sep. PMID 37680944
- BACKGROUNDSun XS, Liu SL, Luo MJ, Li XY, Chen QY, Guo SS, Wen YF, Liu LT, Xie HJ, Tang QN, Liang YJ, Yan JJ, Lin DF, Bi MM, Liu Y, Liang YF, Ma J, Tang LQ, Mai HQ. The Association Between the Development of Radiation Therapy, Image Technology, and Chemotherapy, and the Survival of Patients With Nasopharyngeal Carcinoma: A Cohort Study From 1990 to 2012. Int J Radiat Oncol Biol Phys. 2019 Nov 1;105(3):581-590. doi: 10.1016/j.ijrobp.2019.06.2549. Epub 2019 Jul 15.