Clinical trial NCT06454097: Study on Radiogenomics Features Associated With Radiochemotherapy Sensitivity in Gliomas
Official title: Study on Radiogenomics Features Associated With Radiochemotherapy Sensitivity in Gliomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioma
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The MRI data were collected from patients with gliomas before surgery, 2 weeks before initiating radiochemotherapy, 1 month after completing the radiotherapy (for lower-grade gliomas, LGG), or 4 and 10 months after completing the radiochemotherapy (for high-grade gliomas, HGG). Radiochemotherapy sensitivity labels were constructed based on the MRI images obtained before and after radiochemotherapy, following the RANO criteria. Radiomics features were extracted from preoperative MRI images and combined with transcriptomic information obtained from tumor tissue sequencing. This process allowed the construction of a radiogenomics model capable of predicting the response of gliomas to radiochemotherapy.

In this prospective cohort study, we will recruit patients with gliomas who have undergone craniotomy and received postoperative radiotherapy or radiochemotherapy (in cases of LGG and HGG, respectively). MRI images of the same sequences will be collected at corresponding time points, and transcriptomic sequencing will be performed on tumor tissue obtained during surgery. The established model will be applied to predict radiochemotherapy sensitivity and compared with the 'true' radiochemotherapy sensitivity labels, which are constructed based on the RANO criteria, to evaluate the predictive performance of the model.

Detailed description: This trial aims to recruit 100 cases of LGG and 100 cases of HGG based on statistical calculations. MRI data, including T1-weighted, T2-weighted, T1 contrast-enhanced, and T2-Fluid Attenuated Inversion Recovery (FLAIR) sequences, will be collected before surgery, 2 weeks before initiating radiochemotherapy, 1 month after completing the radiotherapy (LGG), or 4 and 10 months after completing the radiochemotherapy (HGG).

The collected MRI images before and after radiochemotherapy will be used to assess changes in tumor volume. The RANO criteria will be employed to determine the tumor's sensitivity to radiochemotherapy: a complete response and partial response will be classified as sensitive, while stable disease and disease progression will be considered insensitive.

Radiomics features will be extracted using the open-source 'PyRadiomics' python package after performing image preprocessing and segmentation. Transcriptomic data will be obtained by conducting RNA sequencing analysis on tumor samples collected during surgery. Selected radiogenomic features will be incorporated into a pre-constructed machine learning model to predict the sensitivity of gliomas to radiochemotherapy. The model's performance will be evaluated using metrics such as classification accuracy (ACC), area under the receiver operating characteristic curve (AUC), positive predictive value (PPV), and negative predictive value (NPV).

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 or older
* Histologically confirmed glioma
* No history of other brain tumors or previous cranial surgeries
* No history of preoperative radiotherapy or chemotherapy
* Available preoperative, pre-radiotherapy(postoperatively), and post-radiotherapy magnetic resonance imaging (MRI) data

Exclusion Criteria:

* Those who do not meet any of the inclusion criteria

Primary outcomes:
measure: Sensitivity of the AI model in predicting radiochemotherapy respone
timeFrame: 1 month after radiotherapy (LGG); 4 and 10 months after radiochemotherapy (HGG)
measure: Specificity of the AI model in predicting radiochemotherapy respone
timeFrame: 1 month after radiotherapy (LGG); 4 and 10 months after radiochemotherapy (HGG)
measure: Area under the Receiver Operating Characteristic curve (AUC)
timeFrame: 1 month after radiotherapy (LGG); 4 and 10 months after radiochemotherapy (HGG)
Secondary outcomes:
measure: Accuracy of the AI model in predicting radiochemotherapy respone
timeFrame: 1 month after radiotherapy (LGG); 4 and 10 months after radiochemotherapy (HGG)
measure: Positive predictive value (PPV) of the AI model in predicting radiochemotherapy respone
timeFrame: 1 month after radiotherapy (LGG); 4 and 10 months after radiochemotherapy (HGG)
measure: Negative predictive value (NPV) of the AI model in predicting radiochemotherapy respone
timeFrame: 1 month after radiotherapy (LGG); 4 and 10 months after radiochemotherapy (HGG)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Yinyan Wang, MD and PhD
role: PRINCIPAL_INVESTIGATOR
References: