18F-Pentixafor PET in Hematologic Malignancies

Recruiting

• Conditions: Hematological Malignancies
• Interventions: Drug: 18F-Pentixafor

• Registration Number: NCT07122674
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-07-01
• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Primary Completion: 2028-12
• Study Completion: 2029-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age of 18-80 years old, both sexes, with behavioral capacity;
2. patients with suspected or confirmed hematological malignancies;
3. 18F-FDG PET or other imaging examinations should be performed according to the treatment plan;
4. For suspected patients, biopsy or needle biopsy is expected to obtain pathological results;
5. Can provide informed consent, can understand and comply with the requirements of the study.

Exclusion Criteria

1. pregnant and lactating women;
2. patients with fear or radiophobia, or with mental disorder or primary affective disorder;
3. 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;
4. received investigational drugs or devices of uncertain efficacy or safety within 1 month;
5. Any condition that the chairpersons of the study consider that any link related to the study may cause harm or have potential harm.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
18F-Pentixafor PET/CT in Hematologic Malignancies	18F-Pentixafor	Each patient receive a single intravenous injection of 18F-Pentixafor 55 MBq/kg and undergo PET/CT or PET/MR scan after 60 min post-injection.

Primary Outcome Measures

Name	Time	Method
Diagnostic efficacy	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 Outcome Measures

Name	Time	Method
18F-Pentixafor PET performence compared with 18F-FDG	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.
Deauville Score	through study completion, 3-4 years	1. Score consistency analysis Agreement with 18F-FDG: Calculated agreement between the two imaging scores for the same patient (percentage agreement \& Cohen's Kappa).; 2. 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).; 3. score critical value optimization:If the physiological profiles of 18F-Pentixafor and 18F-FDG differ significantly (e.g., higher hepatic uptake), explore adjusted cutoffs

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China