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NCT Number: NCT07122674

18F-Pentixafor PET in Hematologic Malignancies

The aim of this study is to evaluate the efficacy of 18F-Pentixafor PET imaging in the diagnosis, staging and response evaluation of hematological malignancies.

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Key information

Conditions

Hematological Malignancies Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

18F-FDG PET imaging based on the principle of glucose metabolism imaging is currently dominant in the staging and efficacy evaluation of lymphoma, but it is not suitable for a wider range of hematological tumors. Chemokine receptor 4 (CXCR-4) is a G protein-coupled receptor, which is overexpressed in a variety of hematological malignancies (MM, leukemia, lymphoma, etc.). It promotes tumor growth, invasion, metastasis, drug resistance, immune escape, and is associated with poor prognosis of tumors. 18Fluorine18 (18F)-NOTA-Pentixafor (18f-pentixafor) is a novel specific molecular probe targeting CXCR-4. Compared with 68Ga-Pentixafor, 18f-pentixafor has a longer half-life. More patients can be used in one synthesis, and the image quality is better and the spatial resolution is higher. Patients can undergo PET at 1 h after injection without special preparation. The aim of this study is to evaluate the performance of 18F-Pentixafor PET imaging in the diagnosis, staging, and response evaluation of hematological malignancies. Patients with suspected or histologically confirmed hematological malignancies will be enrolled in this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age of 18-80 years old, both sexes, with behavioral capacity;
  • patients with suspected or confirmed hematological malignancies;
  • 18F-FDG PET or other imaging examinations should be performed according to the treatment plan;
  • For suspected patients, biopsy or needle biopsy is expected to obtain pathological results;
  • Can provide informed consent, can understand and comply with the requirements of the study.

Exclusion criteria

  • pregnant and lactating women;
  • patients with fear or radiophobia, or with mental disorder or primary affective disorder;
  • received ionizing radiation outside the scope of this study for clinical medical or scientific research purposes within the past year, resulting in an annual radiation exposure dose exceeding 50 mSv;
  • received investigational drugs or devices of uncertain efficacy or safety within 1 month;
  • Any condition that the chairpersons of the study consider that any link related to the study may cause harm or have potential harm.

Treatment and study plan

18F-Pentixafor

Drug

Patients with hematological malignancies receive 55 MBq/kg of 18F-Pentixafor intravenously followed by PET/CT or PET/MR after 60min of injection.

Primary outcomes

  1. Diagnostic efficacy

    Time frame: through study completion, an average of 1.5 year

    Sensitivity, specificity, positive and negative predictive value of 18F-Pentixafor PET/CT and PET/MR Imaging in hematological malignancies.

Secondary outcomes

  1. 18F-Pentixafor PET performence compared with 18F-FDG

    Time frame: up to 24 months

    Differences in sensitivity and specificity: McNemar test Differences in AUC values: DeLong test Detection rate of lesions: chi-square test. SUVmax/TBR difference: Paired t-test (normal distribution) or Wilcoxon signed-rank test (non-normal) Correlation analysis: Spearman's rank correlation was used to assess the correlation of uptake between the two imaging methods.

    Subgroup analysis: Chi-square test or Logistic regression was used to analyze heterogeneity in diagnostic power stratified by disease type and stage.

  2. Deauville Score

    Time frame: through study completion, 3-4 years

    • Score consistency analysis Agreement with 18F-FDG: Calculated agreement between the two imaging scores for the same patient (percentage agreement & Cohen's Kappa).
    • correlation between scores and clinical outcomes Prediction of treatment response: use the International Working Group criteria (Lugano classification) as the gold standard (complete response CR, partial response PR, etc.) The association between 18F-Pentixafor scores (e.g., DS≤3 vs. DS≥4 after treatment) and treatment response (chi-square test) was calculated.

    Prognostic Value: Analyze the association of 18F-Pentixafor score (e.g., baseline DS≥4) with progression-free survival (PFS) or overall survival (OS) (Cox proportional-hazards model). The prognostic efficacy of 18F-Pentixafor and 18F-FDG scoring was compared (area under the ROC curve, AUC).

    • score critical value optimization:If the physiological profiles of 18F-Pentixafor and 18F-FDG differ significantly (e.g., higher hepatic uptake), explore adjusted cutoffs

Study contacts

Contact information is provided by the study sponsor or research team.

Peipei Wang, MD

CONTACT

[email protected]

86 18511395988

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

Prospective Clinical Study of 18F-Pentixafor PET Imaging in Hematologic Malignancies

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Aug 14, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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