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

NCT06234319 | Recruiting

• 1 other identifier: 20230294
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma

Outcome Measures

Primary Outcomes (3)

• Standardised uptake values

  Standardised uptake values of suspected glioma disease in CXCR4 PET/MRI imaging

  completed within one week after the PET/MRI examination

• expression of CD34

  Immunohistochemical evaluation of the expression of CD34 in postoperative tumor tissue

  completed within one week after surgery

• expression of CXCR4

  Immunohistochemical evaluation of the expression of CXCR4 in postoperative tumor tissue

  completed within one week after surgery

Secondary Outcomes (4)

• SUV and histological grading of glioma

  through study completion, an average of 1 year

• CXCR4 expression and histological grading of glioma

  through study completion, an average of 1 year

• SUV and IDH mutation status

  through study completion, an average of 1 year

• SUV and 1p/19q deletion status

  through study completion, an average of 1 year

Interventions

CXCR4 DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The subjects are adults with newly diagnosed primary glioma, regardless of gender.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xiao Chen: lead

Study Sites (1)

Department of Nuclear Medicine, Daping Hospital of Army Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

Related 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-Pentixather. Eur J Nucl Med Mol Imaging. 2022 Jan;49(2):481-491. doi: 10.1007/s00259-021-05196-4. Epub 2021 Feb 7.

  PMID: 33550492 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

brain glioma resction specimens

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Chen Xiao, Ph.D

  Daping Hospital, Army Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Du ZHenwei, Ph.D

CONTACT

+8618580503880; peter11dzw@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Nuclear Medicine Department

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 31, 2024
• Study Start: February 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)