CXCR4-targeted PET/CT Imaging in Hematological Malignancies

NCT05255926 | Recruiting

• 1 other identifier: ZNYYHYXK0002
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CXCR4; PET/CT; Hematological Malignancy

Outcome Measures

Primary Outcomes (5)

• Diagnostic Accuracy of 68Ga-pentixafor PET/CT Compared to 18F-FDG PET/CT in Hematological Malignancies

  To assess and compare the diagnostic accuracy of 68Ga-pentixafor PET/CT and 18F-FDG PET/CT in patients with newly diagnosed, relapsed, or highly suspected hematological malignancies. Accuracy will be evaluated using a composite reference standard, including histopathological confirmation, clinical follow-up, and additional imaging findings.

  Two years

• Concordance of [⁶⁸Ga]Ga-pentixafor PET/CT with Standard Clinical Staging Systems

  To evaluate the concordance between \[⁶⁸Ga\]Ga-pentixafor PET/CT-based staging and conventional clinical staging systems (e.g., Ann Arbor, Durie-Salmon PLUS, R-ISS/R2-ISS) in patients with hematological malignancies. Concordance will be measured using Cohen's kappa statistic (κ).

  Two years

• Predictive Value of [⁶⁸Ga]Ga-pentixafor PET/CT Parameters for Progression-Free Survival

  To assess whether imaging biomarkers from \[⁶⁸Ga\]Ga-pentixafor PET/CT, such as SUVmax or total lesion CXCR4 uptake, predict progression-free survival (PFS) in patients with hematological malignancies. Comparison will be made with \[¹⁸F\]FDG PET/CT-derived parameters.

  Four years

• Predictive Value of [⁶⁸Ga]Ga-pentixafor PET/CT Parameters for Overall Survival

  To evaluate whether \[⁶⁸Ga\]Ga-pentixafor PET/CT-based biomarkers can predict overall survival in patients with hematological malignancies, compared with \[¹⁸F\]FDG PET/CT.

  Four years

• Dice Similarity Coefficient (DSC) for AI-based lesion segmentation

  Evaluation of the overlap between artificial intelligence-generated lesion segmentations and expert manual annotations on PET/CT images using the Dice similarity coefficient (DSC).

  Two years

Secondary Outcomes (3)

• Correlation Between CXCR4 Expression and [⁶⁸Ga]Ga-pentixafor PET/CT Parameters

  Two years

• Correlation between del(17p) status and TLU on [68Ga]Ga-pentixafor PET/CT

  Two years

• Radiogenomic Model for Risk Prediction Using AI

  Two years

Study Arms (1)

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

EXPERIMENTAL

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.

Drug: 68Ga-pentixafor; Device: PET/CT

Interventions

68Ga-pentixafor DRUG

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

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

PET/CT DEVICE

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

Also known as: Positron Emission Tomography/Computed Tomography

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

Related Publications (3)

• Herrmann K, Lapa C, Wester HJ, Schottelius M, Schiepers C, Eberlein U, Bluemel C, Keller U, Knop S, Kropf S, Schirbel A, Buck AK, Lassmann M. Biodistribution and radiation dosimetry for the chemokine receptor CXCR4-targeting probe 68Ga-pentixafor. J Nucl Med. 2015 Mar;56(3):410-6. doi: 10.2967/jnumed.114.151647. Epub 2015 Feb 19.

  PMID: 25698782 BACKGROUND

• Pan Q, Cao X, Luo Y, Li J, Feng J, Li F. Chemokine receptor-4 targeted PET/CT with 68Ga-Pentixafor in assessment of newly diagnosed multiple myeloma: comparison to 18F-FDG PET/CT. Eur J Nucl Med Mol Imaging. 2020 Mar;47(3):537-546. doi: 10.1007/s00259-019-04605-z. Epub 2019 Nov 27.

  PMID: 31776631 BACKGROUND

• Duell J, Krummenast F, Schirbel A, Klassen P, Samnick S, Rauert-Wunderlich H, Rasche L, Buck AK, Wester HJ, Rosenwald A, Einsele H, Topp MS, Lapa C, Kircher M. Improved Primary Staging of Marginal-Zone Lymphoma by Addition of CXCR4-Directed PET/CT. J Nucl Med. 2021 Oct;62(10):1415-1421. doi: 10.2967/jnumed.120.257279. Epub 2021 Feb 12.

  PMID: 33579803 BACKGROUND

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

68Ga-pentixafor; Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Yong He, MD, PhD

  Zhongnan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong He, MD, PhD

CONTACT

+86-27-67812698; vincentheyong@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 25, 2022
• Study Start: March 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)