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

Recruiting

• Conditions: Glioma

• Registration Number: NCT06234319
• Lead Sponsor: Xiao Chen

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-01-31
• Study Start: 2024-02-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-03
• Last Update Posted: 2024-03-05
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients diagnosed with primary glioma based on clinical, imaging, and histopathological 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 Criteria

1. Pregnant or breastfeeding patients;
2. The image quality of the imaging is poor and cannot be used for diagnosis and evaluation;
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 patients with renal insufficiency.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Standardised uptake values	completed within one week after the PET/MRI examination	Standardised uptake values of suspected glioma disease in CXCR4 PET/MRI imaging
expression of CD34	completed within one week after surgery	Immunohistochemical evaluation of the expression of CD34 in postoperative tumor tissue
expression of CXCR4	completed within one week after surgery	Immunohistochemical evaluation of the expression of CXCR4 in postoperative tumor tissue

Secondary Outcome Measures

Name	Time	Method
SUV and IDH mutation status	through study completion, an average of 1 year	Correlation between SUV and IDH mutation status
SUV and histological grading of glioma	through study completion, an average of 1 year	Correlation between SUV and histological grading of glioma
CXCR4 expression and histological grading of glioma	through study completion, an average of 1 year	Correlation between CXCR4 expression and histological grading of glioma
SUV and 1p/19q deletion status	through study completion, an average of 1 year	Correlation between SUV and 1p/19q deletion status

Trial Locations

Locations (1)

Department of Nuclear Medicine, Daping Hospital of Army Medical University; 🇨🇳 Chongqing, Chongqing, China