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18F-Pentixafor PET in Hematologic Malignancies

ConditionHematological Malignancies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial population

patients with suspected or confirmed Hematologic Malignancies

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: 18F-Pentixafor PET/CT in Hematologic Malignancies1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic efficacy

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

Time frame
through study completion, an average of 1.5 year

Secondary outcomes

1

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

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.

Time frame
up to 24 months
2

Deauville Score

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

Time frame
through study completion, 3-4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Zhejiang University

Lead sponsor

Source ClinicalTrials.gov
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