Clinical trial NCT06244394: Retrospective Study on the Prediction of Radiation-induced Brain Injury in Patients With Nasopharyngeal Carcinoma
Official title: A Retrospective Study to Establish a Prediction Model for Radiation-induced Brain Damage in Nasopharyngeal Carcinoma Patients Based on Pretreatment Imaging and Radiotherapy Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasopharyngeal Carcinoma
Radiation-Induced Temporal Lobe Injury
Keywords: radiomics
machine learning
deep learning
Lead sponsor: Jiangsu Cancer Institute & Hospital
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: nasopharyngeal carcinoma paients who recieved intensity-modulated radiotherapy

Brief summary: Radiation therapy has become the preferred treatment for nasopharyngeal cancer due to the sensitivity of nasopharyngeal carcinoma to radiation. However, even with the use of intensity-modulated radiation therapy (IMRT), radiation-induced temporal lobe injury (RTLI) can be a severe complication. Patients with RTLI may experience long-term memory loss, personality changes, physical dysfunctions, and other symptoms, which seriously impair their quality of life and long-term prognosis. Currently, the diagnosis of RTLI primarily relies on clinical symptoms and imaging examinations such as computed tomography (CT) and conventional MRI. However, these methods only enable the diagnosis of RTLI at a late stage when it is irreversible and cannot be effectively treated. Therefore, the early identification or individualized prediction of RTLI after IMRT holds exceptional importance for improving the quality of life in nasopharyngeal carcinoma patients.

The exact mechanism of RTLI remains unclear. Many clinical covariates have been proven to be associated with RTLI in NPC patients, including stage, age, and dosimetric parameters. In addition, it was reported that each patient's temporal lobe exhibits unique genetic susceptibility to radiation exposure. In this study, we aim to predict the occurrence of RTLI by analyzing clinical factors and heterogeneity of temporal lobe tissue prior to irradiation. Finally, we want to construct and validate a prediction model for RLTI, which can support clinician decision-making in developing individualized treatment plans and providing preventive measures.


Eligibility criteria: Inclusion Criteria:

* (1) pathological confirmation of NPC; (2) receipt of IMRT; (3) nasopharynx-neck MRI within 2 weeks before antineoplastic treatment

Exclusion Criteria:

* (1) temporal lobe invasion; (2) with central nervous system diseases except RTLI; (3) receiving additional radiation after IMRT; (4) incomplete clinical or imaging data

Primary outcomes:
measure: NPC patients with RTLI
timeFrame: three years
measure: NPC patients without RTLI
timeFrame: three years
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
Study officials:
References: