Value of Chemokine Receptor CXCR4 Imaging for Diagnosis and Prognostic Evaluation in Lymphoproliferative Diseases
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1 lymphoma
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2020
CompletedFirst Posted
Study publicly available on registry
August 7, 2020
CompletedStudy Start
First participant enrolled
August 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedSeptember 15, 2023
February 1, 2023
4.3 years
August 1, 2020
September 14, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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.
through study completion, an average of 3 years
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.
through study completion, an average of 3 years
Secondary Outcomes (1)
Diagnostic sensitivity and specficity in special type of lymphoma
through study completion, an average of 3 years
Study Arms (1)
68Ga-Pentixafor, PET/CT
EXPERIMENTALPET/CT perform after injecting 68Ga-Pentixafor
Interventions
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.
Eligibility Criteria
You may qualify if:
- suspected or confirmed untreated Lymphoproliferative diseases patients
- F-FDG PET/CT within two weeks
- signed written consent.
You may not qualify if:
- pregnancy
- breastfeeding
- known allergy against Pentixafor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
Related Publications (2)
Pan Q, Chen Z, Liu S, Zhang H, Feng J, Miao W, Li F, Cao X, Luo Y. Reduced splenic uptake of [68Ga]Ga-Pentixafor following first-line chemotherapy is associated with poor prognosis in patients with newly diagnosed multiple myeloma. EJNMMI Res. 2025 Jun 20;15(1):74. doi: 10.1186/s13550-025-01262-2.
PMID: 40540129DERIVEDChen Z, Yang A, Zhang J, Chen A, Zhang Y, Huang C, Chen S, Yao S, Miao W. CXCR4-Directed PET/CT with [68Ga]Pentixafor in Central Nervous System Lymphoma: A Comparison with [18F]FDG PET/CT. Mol Imaging Biol. 2022 Jun;24(3):416-424. doi: 10.1007/s11307-021-01664-3. Epub 2021 Oct 14.
PMID: 34651291DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weibing Miao, M.D.
First Affiliated Hospital of Fujian Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Nuclear Medicine Department
Study Record Dates
First Submitted
August 1, 2020
First Posted
August 7, 2020
Study Start
August 7, 2020
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
September 15, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share