CXCR4-targeted PET/CT Imaging in Hematological Malignancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Hematological malignancies continue to pose significant clinical challenges due to their high incidence, heterogeneous biology, and substantial mortality. Although 18F-FDG PET/CT remains the most commonly used molecular imaging modality, its limited specificity can result in false-positive or false-negative findings, especially in indolent or low-metabolism subtypes, thereby hampering accurate diagnosis, staging, and therapeutic evaluation. C-X-C chemokine receptor type 4 (CXCR4) is frequently overexpressed in a broad spectrum of hematologic malignancies and correlates with aggressive disease and unfavorable outcomes. CXCR4-targeted molecular imaging using \^68Ga-pentixafor PET/CT has shown promise for improved disease characterization. This prospective study aims to systematically compare 68Ga-pentixafor PET/CT with 18F-FDG PET/CT in terms of diagnostic performance, staging accuracy, risk stratification, and prognostic relevance in patients with hematological malignancies. Furthermore, the study will incorporate artificial intelligence-based image analysis to enhance lesion detection, automate quantitative assessments, and support personalized clinical decision-making.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Value of Chemokine Receptor CXCR4 Imaging for Diagnosis and Prognostic Evaluation in Lymphoproliferative Diseases

NCT04504526

Lymphoma Multiple Myeloma Leukemia

UNKNOWN EARLY_PHASE1

Chemokine Receptor 4 PET/CT Imaging of CXCR4-Related Diseases

NCT06690736

RECRUITING NA

Chemokine Receptor CXCR4-targeting Molecular Imaging for Metabolic Characterization of Multiple Myeloma and Lymphoma

NCT03436342

Multiple Myeloma Lymphoma

UNKNOWN EARLY_PHASE1

68Ga-pentixather and 68Ga-pentixafor PET/CT in Multiple Myeloma

NCT05364177

Multiple Myeloma

UNKNOWN EARLY_PHASE1

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

NCT06234319

Glioma

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Hematological malignancies encompass a heterogeneous group of neoplasms originating from the bone marrow and lymphatic system. Despite advances in therapeutic strategies, the prognosis for many subtypes remains suboptimal, and accurate initial evaluation is critical for appropriate treatment planning. \^18F-FDG PET/CT is routinely used for functional imaging in these patients; however, its diagnostic utility is limited by variable glucose metabolism across disease subtypes and inflammatory uptake, which can lead to misclassification.

CXCR4, a chemokine receptor involved in tumor proliferation, invasion, and microenvironmental interactions, is overexpressed in numerous hematologic malignancies and has emerged as a molecular target for both imaging and therapy. 68Ga-pentixafor, a CXCR4-targeted PET radiotracer, has demonstrated superior lesion detection in preliminary studies, particularly in diseases with low 18F-FDG avidity.

This prospective study will investigate the clinical utility of 68Ga-pentixafor PET/CT in patients with newly diagnosed or relapsed hematological malignancies. Comparative analyses with 18F-FDG PET/CT will be performed to assess concordance, staging accuracy, and association with known risk stratification systems. Longitudinal follow-up will be conducted to evaluate the prognostic relevance of imaging findings.

In parallel, the study will explore the application of artificial intelligence (AI) techniques, including deep learning-based image segmentation and radiomic feature extraction, to enhance diagnostic precision and support risk-adapted management strategies. AI-driven models will be developed and validated to predict disease burden, progression, and survival, thereby contributing to personalized medicine in hematologic oncology.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

CXCR4 PET/CT Hematological Malignancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

68Ga-pentixafor and 18F-FDG PET/CT

Patients with a high clinical suspicion of, or confirmed newly diagnosed or relapsed hematological malignancies will be recruited. All enrolled patients will undergo both 68Ga-pentixafor and 18F-FDG PET/CT imaging within two weeks.

Group Type EXPERIMENTAL

68Ga-pentixafor

Intervention Type DRUG

All participants undergo intravenous administration of 68Ga-pentixafor (1.85-3.71 MBq/kg body weight).

PET/CT

Intervention Type DEVICE

PET/CT imaging is performed 1 h after intravenous injection of 68Ga-pentixafor.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

68Ga-pentixafor

All participants undergo intravenous administration of 68Ga-pentixafor (1.85-3.71 MBq/kg body weight).

Intervention Type DRUG

PET/CT

PET/CT imaging is performed 1 h after intravenous injection of 68Ga-pentixafor.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Positron Emission Tomography/Computed Tomography

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Volunteer to participate and sign an informed consent form;
2. 18 ≤ Age ≤ 90 years;
3. Patients with highly suspected, or newly diagnosed, or relapsed hematological malignancies;
4. Willing and able to follow schedule visits, treatment plans and laboratory tests.

Exclusion Criteria

1. pregnancy or breastfeeding;
2. Allergic to CXCR4-targeted tracers or excipients;
3. Fasting blood glucose level exceeded 11.0 mmol/L prior to injection of 18F-FDG;
4. Those who cannot complete PET/CT scan, including inability to keep supine, claustrophobia, radiation phobia, etc.;
5. Researchers think it is inappropriate to participate in this clinical trial for patients with poor compliance or other unsuitable factors.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No