RecruitingNot ApplicableNCT05255926

CXCR4-targeted PET/CT Imaging in Hematological Malignancies

An Exploratory, Open-Label, Single Center Study of CXCR4-targeted PET/CT Imaging for Evaluation of Hematological Malignancies


Sponsor

Zhongnan Hospital

Enrollment

300 participants

Start Date

Mar 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria4

  • Volunteer to participate and sign an informed consent form;
  • 18 ≤ 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.

Exclusion Criteria5

  • 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.

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Interventions

DRUG68Ga-pentixafor

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

DEVICEPET/CT

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


Locations(1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

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NCT05255926


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