NCT07198256

Brief Summary

This study aims to establish a large-scale, multi-center MRI database for malignant brain tumors. It will develop an artificial intelligence system for the segmentation and classification of multiple subtypes of brain tumors (including glioma, metastatic tumor and lymphoma et al.) using deep learning technology. This will address the issues of small sample sizes and limited classification performance in existing methods, thereby improving the accuracy of non-invasive preoperative diagnosis, reducing the need for biopsies, and having significant clinical translational value.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Sep 2025

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Sep 2025Dec 2028

Study Start

First participant enrolled

September 1, 2025

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Expected
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

September 22, 2025

Last Update Submit

September 22, 2025

Conditions

Keywords

brain tumorgliomabrain metastaseslymphomamagnetic resonance imagingartificial intelligence

Outcome Measures

Primary Outcomes (1)

  • Construct an AI-assisted diagnostic system for multiple subtypes of brain tumors based on deep learning.

    Construct an AI-assisted diagnostic system for multiple subtypes of brain tumors based on deep learning, mainly including glioma, metastatic tumor and lymphoma.

    30 days

Study Arms (1)

malignant brain tumors

Retrospectively collected cases of malignant brain tumors (including gliomas, brain metastases, and brain lymphomas) that were confirmed by histopathology and had preoperative multimodal MRI images (mainly including CE-T1WI and T2-FLAIR) over the past 10 years

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retrospectively collected cases of malignant brain tumors (including gliomas, brain metastases, and brain lymphomas) that were confirmed by histopathology and had preoperative multimodal MRI images (mainly including CE-T1WI and T2-FLAIR) over the past 10 years.

You may qualify if:

  • Patients diagnosed with glioma, brain metastases, and brain lymphoma by pathology, with the patient being at least 18 years old; preoperative MRI was complete.

You may not qualify if:

  • Poor image quality; history of previous brain surgery or radiotherapy; accompanied by other intracranial lesions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

NOT YET RECRUITING

MeSH Terms

Conditions

GliomaBrain NeoplasmsLymphoma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2025

First Posted

September 30, 2025

Study Start

September 1, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2028

Last Updated

September 30, 2025

Record last verified: 2025-09

Locations