NCT04908267

Brief Summary

High-grade glioma is the most common primary malignant tumor in central nervous system, and its high tumor heterogeneity is the main cause of tumor progression, treatment resistance and recurrence. Habitat imaging is a segmentation technique by dividing tumor regions to characterize tumor heterogeneity based on tumor pathology, blood perfusion, molecular characteristics and other tumor biological features. In some studies, the Hemodynamic Multiparametric Tissue Signature (HTS) method has been proven to be feasible. The Hemodynamic Multiparametric Tissue Signature (HTS) consists of a set of vascular habitats obtained by Dynamic Susceptibility Weighted Contrast Enhanced Magnetic Resonance Imaging (DSC-MRI) of high-grade gliomas using a multiparametric unsupervised analysis method. This allowed them to automatically draw 4 reproducible vascular habitats (High-angiogenic enhancing tumor; Low-angiogenic enhancing tumor; Potentially tumor infiltrated peripheral edema; Vasogenic peripheral edema) which enable to describe the tumor vascular heterogeneity robustly. In other studies, contrast-enhancing mass can divided into spatial habitats by K-means clustering of voxel-wise apparent diffusion coefficient (ADC) and cerebral blood volume (CBV) values to observe the changes of voxels in spatial habitat on the time line. Using this so-called spatiotemporal habitat to identify progression or pseudoprogression in cancer therapy. Above all, we have sufficient and firm reasons to deem that habitat imaging based on multiparametric MRI is more conducive to reflect the potential biological information inside the tumor and realize individualized diagnosis and treatment. To sum up, the assumption of this experiment is that the Habitats Created by preoperative or postoperative Multiparametric MRI ,such as conventional MRI sequences, Dynamic Susceptibility Weighted Contrast Enhanced Magnetic Resonance Imaging (DSC-MRI), Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI), Diffusion Weighted Magnetic Resonance Imaging(DWI) ,Vessel Size Imaging (VSI) ,or Magnetic Resonance Spectroscopy (MRS) can predict the molecular mutation status, prognosis, treatment residence, progression, pseudoprogression, and even recurrence and distant intracranial recurrence in patients with high-grade gliomas.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 1, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

2.4 years

First QC Date

May 17, 2021

Last Update Submit

January 8, 2023

Conditions

Keywords

habitat imaginghigh-grade gliomaradiomicsheterogeneityrecurrence

Outcome Measures

Primary Outcomes (1)

  • Multi-model habitats constructed by multiparametric MRI predict IDH mutation status and the prognosis in high-grade gliomas

    The IDH status of each patient was dependent on pathological and immunohistochemical results. The overall survival for each patient is estimated since the date of operation to the end of recruitment. The overall survival will be confirmed through clinical follow-up.

    From the date of operation until the date of death from any cause,assessed up to 120 months

Eligibility Criteria

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

The subjects we selected are adults who are not restricted by gender. For details, please refer to the "criteria" column.

You may qualify if:

  • the patient was over 18 years old
  • the lesion was located in the supratentorial space;
  • a histopathologic diagnosis of HGGs according to the WHO CNS4/5;
  • all subjects were the first diagnosed cases without any invasive or non-invasive treatment;
  • access to the complete preoperative MR imaging examinations, at least including four conventional sequences.
  • the patient was over 18 years old;
  • the lesion was located in the supratentorial space;
  • a histopathologic diagnosis of HGGs according to the WHO CNS4/5;
  • underwent concurrent chemoradiotherapy with temozolomide after surgical resection or biopsy;
  • underwent preoperative and postoperative MRI, at least including four conventional sequences;
  • had newly appeared or enlarging, measurable, contrast-enhancing mass which raises clinical suspicion of tumor recurrence and distant intracranial recurrence;
  • adequate follow-up examinations to determine treatment response on clinic-radiological consensus or pathologic confirmation.

You may not qualify if:

  • patient with other brain tumors or other grade gliomas at the same time;
  • patient with severe basic diseases at the same time;
  • patient with a survival time of less than 30 days, which can be caused by severe surgical trauma stress;
  • poor image quality and heavy artifact affect the subsequent image processing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiology, Daping Hospital of Army Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Related Publications (1)

  • Wu H, Tong H, Du X, Guo H, Ma Q, Zhang Y, Zhou X, Liu H, Wang S, Fang J, Zhang W. Vascular habitat analysis based on dynamic susceptibility contrast perfusion MRI predicts IDH mutation status and prognosis in high-grade gliomas. Eur Radiol. 2020 Jun;30(6):3254-3265. doi: 10.1007/s00330-020-06702-2. Epub 2020 Feb 20.

    PMID: 32078014BACKGROUND

Related Links

MeSH Terms

Conditions

GliomaRecurrence

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Weiguo Zhang, Ph.D

    Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiachen Liu, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Radiology Department

Study Record Dates

First Submitted

May 17, 2021

First Posted

June 1, 2021

Study Start

August 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 11, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations