Radiomics-Based Visualization and Quantitative Validation of IDH1 Heterogeneity in Gliomas

NCT05969691 | Active Not Recruiting

• 1 other identifier: MINGGE-SW-00003-V1-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trail is to non-invasively visualise and quantitatively validate an radiomics model of genetic heterogeneity in adult patients with diffuse glioma to help clinicians better guide surgical resection and treatment options. It aims to answer are:

1. 1.To overcome the limitations of the existing genetic diagnostic process in terms of equipment and technology requirements, high costs and long timelines, and to enable quantitative studies of isocitrate dehydrogenase 1 (IDH1) mutations, thus allowing refined patient stratification and further exploration of the role of molecular markers in improving patient prognosis.
2. 2.To achieve non-invasive diagnosis of gene mutations within tumours by taking advantage of artificial intelligence and medical images, and to test the clinical feasibility of the model through typical target puncture, gene sequencing and quantitative gene expression analysis.

Conditions

Glioma, Malignant; Computer-Assisted

Keywords

Genetic Heterogeneity; Gliomas; Computer-Assisted Diagnosis

Outcome Measures

Primary Outcomes (1)

• accuracy

  The ratio of correct model predictions to all predictions is calculated by comparing the results with the puncture results.

  End of study (24 weeks)

Study Arms (1)

Validation of IDH1 mutations from the radiomics model

EXPERIMENTAL

In this experiment, we validate the accuracy of radiomics model for IDH1 prediction by puncturing typical targets of gliomas, gene sequencing and quantitative gene analysis.

Diagnostic Test: Validation of IDH1 mutations from the radiomics model

Interventions

Validation of IDH1 mutations from the radiomics model DIAGNOSTIC_TEST

During surgery, clinicians will select several typical target sites for puncture based on the preoperative model outputs. After surgery, the acquired tumour tissues will be subjected to histological diagnosis and pathological diagnosis by professional pathologists, and the results will be compared with the model output to verify its accuracy.

Validation of IDH1 mutations from the radiomics model

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-70 years, male or female;
• Patients with complete preoperative magnetic resonance imaging and were initially diagnosed with glioma based on the magnetic resonance imaging results;
• Patients who were proposed for craniectomy without contraindications to surgery and who had signed an informed consent form by themselves or their proxy;
• Patients with confirmed diagnosis of glioma by postoperative pathological diagnosis.

You may not qualify if:

• Patients to be admitted for a simple puncture biopsy;
• Patients with a combination of serious medical conditions and those who cannot tolerate surgery;
• Patients with a bleeding tendency or abnormal coagulation function, or those who have not discontinued long-term use of anticoagulants such as aspirin and clopidogrel;
• Pregnant and breastfeeding women;
• Patients participate in other clinical trials during the same period.

Sponsors & Collaborators

• Mingge LLC: lead
• Huashan Hospital: collaborator
• Fudan University: collaborator

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Ying Mao, DM

  Huashan Hospital

  STUDY CHAIR

• Zhifeng Shi, DM

  Huashan Hospital

  STUDY DIRECTOR

• Jinhua Yu, DE

  Fudan University

  STUDY DIRECTOR

• Zengxin Qi, DM

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2023
• First Posted: August 1, 2023
• Study Start: March 15, 2019
• Primary Completion: December 15, 2025
• Study Completion (Estimated): December 15, 2026
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)