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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06234319
Enrollment
60
Registered
2024-01-31
Start date
2024-02-15
Completion date
2025-12-31
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma

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.

Interventions

DIAGNOSTIC_TESTCXCR4

Patients with clinical suspected primary glioma will receive a CXCR4 PET imaging.

Sponsors

Xiao Chen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Standardised uptake valuescompleted within one week after the PET/MRI examinationStandardised uptake values of suspected glioma disease in CXCR4 PET/MRI imaging
expression of CD34completed within one week after surgeryImmunohistochemical evaluation of the expression of CD34 in postoperative tumor tissue
expression of CXCR4completed within one week after surgeryImmunohistochemical evaluation of the expression of CXCR4 in postoperative tumor tissue

Secondary

MeasureTime frameDescription
SUV and histological grading of gliomathrough study completion, an average of 1 yearCorrelation between SUV and histological grading of glioma
SUV and 1p/19q deletion statusthrough study completion, an average of 1 yearCorrelation between SUV and 1p/19q deletion status
CXCR4 expression and histological grading of gliomathrough study completion, an average of 1 yearCorrelation between CXCR4 expression and histological grading of glioma
SUV and IDH mutation statusthrough study completion, an average of 1 yearCorrelation between SUV and IDH mutation status

Countries

China

Contacts

Primary ContactDu ZHenwei, Ph.D
peter11dzw@126.com+8618580503880

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026