Radiomics for Preoperative Jaw Cyst Differentiation

September 13, 2024 updated by: huangzhiquan, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Preoperative Differentiation of Jaw Cystic Lesions Based on Radiomics From Computed Tomography Images: A Multicenter, Prospective Machine Learning Study

This study focuses on jawbone cystic lesions, including odontogenic tumors like ameloblastoma and various cysts. Treatment approaches differ; ameloblastomas often require surgical excision due to potential recurrence and metastasis, while cystic lesions may be treated with curettage and marsupialization. Accurate preoperative diagnosis is crucial for optimal treatment outcomes, as inappropriate choices can lead to delayed treatment or overtreatment, affecting patient quality of life. Currently, there is no standard protocol for differential diagnosis, highlighting the need for a predictive diagnostic model.

The study will be a multicenter, prospective machine learning research involving 300 patients across 12 centers. It aims to enhance a previously developed predictive model that integrates machine learning with CT radiomics. Patients will be grouped based on imaging modalities, with data processed uniformly to improve diagnostic predictions. Inclusion criteria ensure comprehensive preoperative data, while exclusion criteria eliminate incomplete or previously treated cases. The study seeks to optimize the model's performance and provide valuable clinical insights.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Jawbone cystic lesions include odontogenic tumors and non-tumorous cystic lesions occurring within the jawbone, with ameloblastoma being the most common among the former, and odontogenic and non-odontogenic cysts among the latter. Currently, the treatment focus varies for different types of jawbone cystic lesions. Ameloblastomas, which may recur and metastasize, are primarily treated with surgical excision, while cystic lesions are more broadly treated with procedures like curettage and marsupialization. Therefore, accurate preoperative differential diagnosis of various jawbone lesions and the subsequent selection of appropriate treatment plans are crucial for achieving optimal patient outcomes. Inappropriate treatment choices may delay the condition or lead to overtreatment, affecting the patient's quality of life. At present, there is still a lack of an objective and accurate standard and differential diagnosis protocol for the treatment of jawbone cystic lesions, making the establishment of an objective and scientific preoperative diagnostic prediction model of significant clinical importance. In previous research, investigators successfully developed an effective predictive diagnostic model by integrating machine learning techniques with computed tomography (CT) radiomics, achieving a maximum AUC ( area under curve ) value >0.8, indicating good predictive performance and clinical reference value. In the current study, investigators aim to conduct a multicenter, prospective machine learning study to further enhance the model's predictive diagnostic performance and assist clinical diagnosis and treatment.

This study is designed as a multicenter, prospective machine learning study, involving 300 patients with jawbone cystic lesions across 12 centers, as detailed in the list of collaborating institutions. Based on research group's previous investigation of the actual diagnostic and treatment conditions at each research center, investigators plan to utilize different types of imaging data for grouping according to the imaging examinations conducted, and to standardize the processing of imaging data from different units and types for subsequent work. Sun Yat-sen Memorial Hospital of Sun Yat-sen University will serve as the main center, with other institutions as sub-centers. The specific grouping is as follows: the spiral CT group includes six general hospitals; the cone beam CT (CBCT) group includes one general hospital and five specialized dental hospitals.

During the study, after enrolling participants who meet the inclusion criteria, investigators will collect maxillofacial CT imaging data, import them into the software (LIFEx version 6.30), and delineate the region of interest (ROI). Radiomic features within the ROI will be extracted using Pyradiomics software, selected, and used for preoperative diagnostic predictions with the existing model. After surgical treatment, the pathological results of the lesions will be tracked and recorded. If conditions permit, the model's predictive performance can be further optimized in phases during the study, or methodological adjustments and reconstructions of the predictive model can be attempted using all available data to achieve a more ideal preoperative diagnostic prediction.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Sun Yat-sen Memorial Hospital，Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of patients who visit various research centers, undergo preliminary examinations, and are clinically diagnosed with jawbone cystic lesions. If patients express a willingness to pursue further treatment, additional relevant examinations will be completed during subsequent diagnosis and treatment. Patients will be screened according to inclusion and exclusion criteria, informed about the details of the study, and asked if they are willing to participate. If patients agree to participate, they can be enrolled into the study population.

Description

Inclusion Criteria:

  • first-time visitors who have not received other treatment interventions;
  • participants with complete preoperative medical records, imaging examinations, and imaging data;
  • participants who have undergone maxillofacial CT examination preoperatively, with complete CT data, no artifact interference in the lesion area, and a lesion size with the longest diameter of at least 2 cm;
  • participants who can tolerate surgical treatment, with specimens sent for routine pathological examination after surgery.

Exclusion Criteria:

  • incomplete medical records, such as missing specialized examination and treatment operation records;
  • patients who received therapeutic operations at other hospitals at first diagnosis, not fully cured or with recurrence;
  • patients who did not undergo CT examination preoperatively, with incomplete CT data, severe artifact interference in the lesion area, or lesion size not meeting requirements;
  • lesions not submitted as specimens for examination during surgery, with no routine pathological examination;
  • unclear postoperative pathology reports, or pathological diagnoses other than odontogenic cysts or non-solid ameloblastoma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
spiral CT
Diagnostic test: different types of computed tomography (CT) scans
For enrolled patients with jaw cystic lesions, depending on their group, either a maxillofacial spiral CT scan or a cone beam CT scan is performed before surgical treatment.
cone beam CT
Diagnostic test: different types of computed tomography (CT) scans
For enrolled patients with jaw cystic lesions, depending on their group, either a maxillofacial spiral CT scan or a cone beam CT scan is performed before surgical treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Statistical Analysis Metrics for Machine Learning Model Predictions
Time Frame: 2025.06-2026.01
Area Under the ROC Curve，Accuracy，Sentivity，Specificity...
2025.06-2026.01

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Collaborators

Xiangya Hospital of Central South University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Air Force Military Medical University, China
Central South University
First Affiliated Hospital of Xinjiang Medical University
Stomatological Hospital, Southern Medical University
Hospital of Stomatology, Sun Yat-Sen University
Hospital of Stomatology, Wuhan University
The People's Hospital Of QianNan
Guangxi Medical University College of Stomatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

August 28, 2024

First Submitted That Met QC Criteria

August 28, 2024

First Posted (Actual)

August 30, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 13, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • SYSKY-2024-432-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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