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

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06234319
• Other study ID #: 20230294
• Status: Recruiting
• Start date: February 15, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Du ZHenwei, Ph.D
• Phone: +8618580503880
• Email: peter11dzw[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioma

Intervention

Diagnostic Test:
• CXCR4
Patients with clinical suspected primary glioma will receive a CXCR4 PET imaging.

Locations

Country	Name	City	State
China	Department of Nuclear Medicine, Daping Hospital of Army Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Xiao Chen

Country where clinical trial is conducted

China, 

References & Publications (1)

Jacobs SM, Wesseling P, de Keizer B, Tolboom N, Ververs FFT, Krijger GC, Westerman BA, Snijders TJ, Robe PA, van der Kolk AG. CXCR4 expression in glioblastoma tissue and the potential for PET imaging and treatment with [68Ga]Ga-Pentixafor /[177Lu]Lu-Penti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardised uptake values	Standardised uptake values of suspected glioma disease in CXCR4 PET/MRI imaging	completed within one week after the PET/MRI examination
Primary	expression of CD34	Immunohistochemical evaluation of the expression of CD34 in postoperative tumor tissue	completed within one week after surgery
Primary	expression of CXCR4	Immunohistochemical evaluation of the expression of CXCR4 in postoperative tumor tissue	completed within one week after surgery
Secondary	SUV and histological grading of glioma	Correlation between SUV and histological grading of glioma	through study completion, an average of 1 year
Secondary	CXCR4 expression and histological grading of glioma	Correlation between CXCR4 expression and histological grading of glioma	through study completion, an average of 1 year
Secondary	SUV and IDH mutation status	Correlation between SUV and IDH mutation status	through study completion, an average of 1 year
Secondary	SUV and 1p/19q deletion status	Correlation between SUV and 1p/19q deletion status	through study completion, an average of 1 year