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Multi-Dimensional MRI Spatial Heterogeneity Analysis for Predicting Key Genes and Prognosis of High-Grade Gliomas: A Multi-Center Study

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ClinicalTrials.gov Identifier: NCT06002711
Recruitment Status : Not yet recruiting
First Posted : August 21, 2023
Last Update Posted : August 21, 2023
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Study Description
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Brief Summary:
  1. To retrospectively explore the feasibility of multi-dimensional heterogeneity imaging features of MRI in predicting the status of key gene mutations in high-grade gliomas;
  2. To prospectively explore the correlation between multi-dimensional heterogeneous MRI image features and prognosis of high-grade glioma patients.

Condition or disease Intervention/treatment
High-grade Glioma Diagnostic Test: MR scanning; Clinical data collection

Detailed Description:

Glioblastoma, the most prevalent primary intracranial tumor, is characterized by its formidable therapeutic resistance, primarily attributed to its intrinsic heterogeneity. This heightened heterogeneity is not solely confined to inter-tumoral variations across different individuals but also encompasses considerable intratumoral diversity. The pervasive notion among the scientific community posits that this intratumoral heterogeneity substantiates an endogenous mechanism for drug resistance, thereby exerting substantial influence upon the design of clinical trials, prognostic prediction, and patient outcomes. Preceding methodologies for assessment are beleaguered by a constellation of challenges, impeding precise evaluation of global tumor heterogeneity and necessitating innovative modalities to surmount this impasse. MRI imaging, endowed with non-invasiveness and user-friendliness, surmounts the biases of single-point sampling, enabling comprehensive and dynamic appraisal of glioblastomas. Notably, high-grade gliomas exhibit pronounced microenvironmental pressure selectivity and adaptability, akin to species occupation within distinct ecological niches. This phenomenon, termed "habitat," manifests as a visual representation of the tumor's spatial distribution and temporal evolution, thus facilitating real-time, longitudinal monitoring. Given the substantial imaging heterogeneity inherent to glioblastomas, they stand as an opportune subject for habitat imaging techniques compared to their neoplastic counterparts.

The present investigation endeavors to leverage multi-center, multi-dimensional MRI spatial heterogeneity analysis to predict pivotal genes germane to prognosis and therapy in high-grade gliomas, ultimately constructing a stratified prognostic model for afflicted patients.

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Multi-Dimensional MRI Spatial Heterogeneity Analysis for Predicting Key Genes and Prognosis of High-Grade Gliomas: A Multi-Center Study
Estimated Study Start Date : September 1, 2023
Estimated Primary Completion Date : September 30, 2026
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
retrospective study cohort
In the retrospective study, patient cases will be gathered from multi-center repositories, where surgical cases will be confirmed to be high-grade gliomas and will undergo preoperative contrast-enhanced MRI examinations. These patients will possess comprehensive clinical, pathological, and genetic data.
 Diagnostic Test: MR scanning; Clinical data collection
Multi-dimensional spatial heterogeneity analysis of MRI
Prospective study cohort
The prospective study will encompass a cohort of individuals who are clinically suspected to have high-grade gliomas and will undergo multimodal MRI imaging. Subsequent to surgery, their postoperative pathology will confirm the diagnosis of high-grade gliomas. Following the surgical intervention, these patients will undergo standard procedures for radiotherapy and chemotherapy, as well as regular follow-up assessments.
 Diagnostic Test: MR scanning; Clinical data collection
Multi-dimensional spatial heterogeneity analysis of MRI


Outcome Measures
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Primary Outcome Measures :
  1. Survival prediction model [ Time Frame: 2025.06-2026.09 ]
    Survival prediction efficiency of the included samples

  2. Time-depended ROC curve [ Time Frame: 2025.06-2026.09 ]
    A time-dependent ROC curve which will be drawn according to the survival analysis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
High-grade glioma patients were recruited from multiple research centers, including Renji Hospital, Shanghai Jiao Tong University School of Medicine, Huashan Hospital, Fudan University; Shanghai Jing'an District Central Hospital, and Nantong First People's Hospital.
Criteria

Inclusion Criteria:

Retrospective Study:

  1. Participants aged 18 to 70 years, of any gender.
  2. Confirmed postoperative pathology of adult diffuse glioma (WHO Grade III-IV).
  3. Standard MR contrast-enhanced imaging performed within 10 days before surgery.
  4. No history of prior radiotherapy or chemotherapy before surgery.
  5. Absence of concurrent significant comorbidities or other tumors.
  6. Presence of molecular testing results (including IDH, MGMT, 1p19q, TERT, CDKN2A/B, BRAF).
  7. Availability of comprehensive clinical and follow-up data.

Prospective Study:

  1. Participants aged 18 to 70 years, of any gender.
  2. Clinically suspected to have high-grade gliomas preoperatively, with final pathology confirming high-grade gliomas.
  3. Stable vital signs and capable of cooperating for a 40-minute MR scan.
  4. Absence of significant underlying medical conditions or history of other tumors.
  5. Documentation of informed consent through a signed consent form.

Exclusion Criteria:

Retrospective Study:

  1. MRI images with artifacts or presence of intratumoral hemorrhage.
  2. Incomplete clinical data available.

Prospective Study:

  1. Individuals with claustrophobia or other reasons unable to undergo MRI scans.
  2. History of allergic reactions to MRI contrast agents.
  3. Inappropriate for prolonged MRI scans due to other reasons.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06002711


Contacts
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Contact: Yan Zhou, MD,PhD +86-021-68383086 clare1475@hotmail.com

Locations
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China, Shanghai
Department of Radiology, Renji hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
RenJi Hospital
More Information
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Publications:

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT06002711    
Other Study ID Numbers: RenJiH-Rad-IIT-2023-0141
IIT-2023-0141 ( Other Identifier: Renji hospital, School of Medicine, Shanghai Jiao Tong University )
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: August 21, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RenJi Hospital:
glioma; MRI; spatial heterogeneity; habitat
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue