Clinical trial NCT06234319: CXCR4 PET/MRI Targeted Imaging for Grading Diagnosis, Molecular Typing, and Prognostic Evaluation of Brain Glioma
Official title: Clinical Study on CXCR4 PET/MRI Targeted Integrated Imaging for Grading Diagnosis, Molecular Typing, and Prognostic Evaluation of Brain Glioma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioma
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects are adults with newly diagnosed primary glioma, regardless of gender.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Standardised uptake values
timeFrame: completed within one week after the PET/MRI examination
measure: expression of CD34
timeFrame: completed within one week after surgery
measure: expression of CXCR4
timeFrame: completed within one week after surgery
Secondary outcomes:
measure: SUV and histological grading of glioma
timeFrame: through study completion, an average of 1 year
measure: CXCR4 expression and histological grading of glioma
timeFrame: through study completion, an average of 1 year
measure: SUV and IDH mutation status
timeFrame: through study completion, an average of 1 year
measure: SUV and 1p/19q deletion status
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University
state: Chongqing
Study officials:
affiliation: Daping Hospital, Army Medical University
name: Chen Xiao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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-Pentixather. Eur J Nucl Med Mol Imaging. 2022 Jan;49(2):481-491. doi: 10.1007/s00259-021-05196-4. Epub 2021 Feb 7.