Value of Chemokine Receptor CXCR4 Imaging for Diagnosis and Prognostic Evaluation in Lymphoproliferative Diseases
Value of Chemokine Receptor CXCR4-targeting Molecular Imaging for Diagnosis and Prognostic Evaluation in Lymphoproliferative Diseases
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Lymphoma:
The marginal zone lymphoma, plasma cell lymphoma, T-cell-lymphoma frequently do not present with an elevated FDG uptake. However, lymphoma is a frequent cancer with high CXCR4 expression. The previous studies showed 68Ga-pentixafor-PET seems to be a highly selective and specific method for the in vivo quantification of CXCR4 expression. Thus, our study is going to investigate the value of 68Ga-pentixafor-PET/CT for the diagnosis and prognostic evaluation of CXCR4 expression in lymphoma.
Multiple myeloma:
Multiple myeloma (MM) is characterized by the neoplastic proliferation of plasma cells producing a monoclonal immunoglobulin. Minimal residual disease (MRD) status is an important predictor of clinical outcome in MM. But it is difficult to assess the accurate MRD status because of the significant heterogeneity characterizing with 18F-FDG PET/CT. Studies showed Chemokine receptor CXCR4 was expressed in MM cells and CXCR4-targeting molecular imaging-68Ga-Pentixafor PET/CT could be a promising technique to evaluate the extent of MM with higher accuracy. This prospective study is going to investigate the value of 68Ga-Pentixafor PET/CT for the diagnosis and prognostic evaluation of CXCR4 expression in MM.
Leukemia： Leukemia is the second largest family of hematological malignancies after the lymphomas, and, depending on the subtype, may show a considerable overlap of histological features with the latter. The four main kinds of leukemia are, in the order of their prevalence. Imaging has traditionally played a limited role in the work-up of leukemias, with regard to detection, staging, and response assessment. 18F-FDG PET/CT is not recommended for routine evaluation of CLL, because the disease shows low uptake in the majority of cases. Although, the clinical utility of MRI lies in the detection of bone marrow abnormalities that are suspicious for leukemia in adult and pediatric patients with unclear musculoskeletal symptoms with its reduced radiation dose (in comparison with PET/CT). However, it may become more attractive with the use of newer, non-FDG PET radiotracers. High CXCR4 expression is known to be associated with poor prognosis in CLL. Recently, the feasibility of 68Ga-Pentixafor PET has also been demonstrated for CLL and AML. This prospective study is going to investigate the value of 68Ga-Pentixafor PET/CT for the diagnosis and prognostic evaluation of CXCR4 expression in leukemia.
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Weibing Miao, M.D.
- Phone Number: +86-599-87981618
- Email: miaoweibing@126.com
Study Contact Backup
- Name: Zhenying Chen
- Phone Number: +86-599-87981619
- Email: chenzhenying726@foxmail.com
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350005
- Recruiting
- Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
-
Contact:
- Weibing Miao, MD
- Phone Number: +86 591 87981618
- Email: miaoweibing@126.com
-
Contact:
- Zhenying Chen, MB
- Phone Number: +86 591 87981619
- Email: 714144972@qq.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- suspected or confirmed untreated Lymphoproliferative diseases patients
- 18F-FDG PET/CT within two weeks
- signed written consent.
Exclusion Criteria:
- pregnancy
- breastfeeding
- known allergy against Pentixafor
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 68Ga-Pentixafor, PET/CT
PET/CT perform after injecting 68Ga-Pentixafor
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SUVmax
Time Frame: through study completion, an average of 3 years
|
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
Time Frame: through study completion, an average of 3 years
|
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 Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Diagnostic sensitivity and specficity in special type of lymphoma
Time Frame: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Weibing Miao, M.D., First Affiliated Hospital of Fujian Medical University
Publications and helpful links
General Publications
- Chen 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Neoplasms, Plasma Cell
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Hemorrhagic Disorders
- Hemic and Lymphatic Diseases
- Leukemia
- Lymphoma
- Multiple Myeloma
- 68Ga-pentixafor
Other Study ID Numbers
- FirstAHFMUCXCR4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.