Radiomics for Preoperative Jaw Cyst Differentiation

NCT ID: NCT06579768

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-05
• Study Completion Date: 2026-01-01

Brief Summary

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.

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.

Conditions

Jawbone Cysitc Lesion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

spiral CT

different types of computed tomography (CT) scans

Intervention Type: DIAGNOSTIC_TEST

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

different types of computed tomography (CT) scans

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital of Stomatology, Wuhan University

OTHER

Sponsor Role: collaborator

Southern Medical University, China

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

Air Force Military Medical University, China

OTHER

Sponsor Role: collaborator

The People's Hospital Of QianNan

UNKNOWN

Sponsor Role: collaborator

Central South University

OTHER

Sponsor Role: collaborator

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role: collaborator

Hospital of Stomatology, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role: collaborator

Guangxi Medical University College of Stomatology

UNKNOWN

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

huangzhiquan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhiquan Huang

Role: CONTACT

hzhquan@mail.sysu.edu.cn

13826142898

Songling Fang

Role: CONTACT

fangsling@mail.sysu.edu.cn

15878920032

Facility Contacts

Zhiquan Huang

Role: primary

hzhquan@mail.sysu.edu.cn

13826142898

References

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

SYSKY-2024-432-02

Identifier Type: -

Identifier Source: org_study_id