Value of Chemokine Receptor CXCR4 Imaging for Diagnosis and Prognostic Evaluation in Lymphoproliferative Diseases

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Fujian Medical University

About this trial

Chemokine receptor CXCR4 is normally expressed on T-lymphocytes, B-lymphocytes, monocytes, macrophages, neutrophils and eosinophils as well as hematopoietic stem and progenitor cells (HSPC) in the bone marrow. 68Ga-Pentixafor PET/CT represents a promising method for the in vivo assessment of the CXCR4 expression status in cancer patients, especially in hematologic malignancies. This prospective study is going to investigate whether metabolic characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, risk stratification, and the prognostic evaluation in lymphoproliferative diseases.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

suspected or confirmed untreated Lymphoproliferative diseases patients

18F-FDG PET/CT within two weeks

signed written consent.

Disqualifiers

pregnancy

breastfeeding

known allergy against Pentixafor

Trial design

Design model

Single group

Treatments tested in this trial

  • 68Ga-Pentixafor

    Drug

    Intravenous injection of one dose of 74-148 MBq (2-4 mCi) 68Ga-Pentixafor. Tracer doses of 68Ga- Pentixafor will be used to image lesions by PET/CT.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: 68Ga-Pentixafor, PET/CTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

SUVmax

SUVmax of focal lesions are measured on 68Ga-Pentixafor PET/CT. The SUVmax of the liver, and/or mediastinal blood pool, and/or L3 vertebra are defined as the background.

Time frame
through study completion, an average of 3 years
2

The time for patient's survival

Investigators follow up and record the time for patient's survival. To investigate the ralationship between initial SUVmax of focal lesions and survival. Finally, the prognostic evaluation of 68Ga-Pentixafor PET/CT for lymphoproliferative diseases in comparison with 18F-FDG PET/CT.

Time frame
through study completion, an average of 3 years

Secondary outcomes

1

Diagnostic sensitivity and specficity in special type of lymphoma

Time frame
through study completion, an average of 3 years

Other outcomes

Sponsors and contacts

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