CXCR4 PET/MRI Targeted Imaging for Grading Diagnosis, Molecular Typing, and Prognostic Evaluation of Brain Glioma

Last updated: March 3, 2024
Sponsor: Xiao Chen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurofibromatosis

Brain Cancer

Cancer/tumors

Treatment

CXCR4

Clinical Study ID

NCT06234319
20230294
  • Ages > 18
  • All Genders

Study Summary

This project intends to evaluate the role of C-X-C chemokine receptor type 4 (CXCR4) targeted PET/MRI integrated imaging in the grading and molecular typing of brain gliomas, using primary glioma patients as the research subjects and post-operative histopathological analysis as the reference, and to establish an evaluation model for the prognosis of primary glioma patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients diagnosed with primary glioma based on clinical, imaging, andhistopathological criteria;
  2. The patient is at least 18 years old;
  3. Participate in CXCR4 PET/MRI imaging within 15 days before surgery;
  4. Surgical resection of glioma lesion tissue can be used for pathological analysis;
  5. The patient voluntarily participates and signs the informed consent form.

Exclusion

Exclusion Criteria:

  1. Pregnant or breastfeeding patients;
  2. The image quality of the imaging is poor and cannot be used for diagnosis andevaluation;
  3. Molecular typing was not determined by histologic examination;
  4. patients with claustrophobia;
  5. Patients who are allergic to radioactive tracers and MRI contrast agents, and patientswith renal insufficiency.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: CXCR4
Phase:
Study Start date:
February 15, 2024
Estimated Completion Date:
December 31, 2025

Study Description

  1. PET/MRI Scan: Image acquisition was completed 15 days before surgery. CXCR4 contrast agent was injected at 6.5 MBq/kg based on body mass, with no drug extravasation, and imaging was performed after 60 minutes of quiet rest. All subjects were scanned in a supine position on a single bed of the Signa™ 3.0T scanner (GE Healthcare Systems), using a 3.0T gem HNU head coil with a scanning field of view focused on the head. PET acquisition lasted for 20 minutes and was reconstructed using OSEM. Simultaneous MRI acquisition included MR-based attenuation correction (MRAC) - zero echo time pulse sequence (ZTE), as well as structural and functional MRI sequences (T1WI, T2WI, FLAIR, DWI, MRS, DSC, T1-CE). Image fusion was performed on a GE post-processing workstation.

  2. Image Analysis and Observation Indicators: PET/MRI images were independently reviewed and processed by two experienced neuroradiologists. Using IKT-SNAP software, target lesion VOIs were outlined based on FLAIR and T1-CE sequences. VOI delineation on the FLAIR sequence included solid tumor components, necrotic areas, and surrounding abnormal FLAIR signal regions. VOI delineation on the T1-CE sequence included enhanced solid components, non-enhanced solid components, and necrotic areas. MRI parameters (diffusion-weighted imaging parameters: ADC; perfusion imaging parameters: CBF, CBV, MTT, TTP; spectroscopic parameters: NAA, Cho, Cr, Lac, NAA/Cr, Cho/Cr) and PET parameters (SUVmax, SUVmean, SUVpeak, CXCR4 metabolic volume, TBR) were measured throughout the tumor and corresponding regions.

  3. Pathological Analysis: Slices containing no less than 25% tumor tissue were used, with each slice having a thickness of 4um. HE, CD34, and CXCR4 immunohistochemical staining were performed separately. Two senior pathologists reviewed the slides using a double-blind method. IDH mutation status and 1p/19q deletion status were determined by the pathology department.

Connect with a study center

  • Department of Nuclear Medicine, Daping Hospital of Army Medical University

    Chongqing, Chongqing 400000
    China

    Active - Recruiting

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