Value of Chemokine Receptor CXCR4 Imaging for Diagnosis and Prognostic Evaluation in Lymphoproliferative Diseases
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|ClinicalTrials.gov Identifier: NCT04504526|
Recruitment Status : Recruiting
First Posted : August 7, 2020
Last Update Posted : August 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Multiple Myeloma Leukemia||Drug: 68Ga-Pentixafor||Early Phase 1|
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 (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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Value of Chemokine Receptor CXCR4-targeting Molecular Imaging for Diagnosis and Prognostic Evaluation in Lymphoproliferative Diseases|
|Estimated Study Start Date :||August 2020|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||December 2023|
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.
- 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.
- 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.
- Diagnostic sensitivity and specficity in special type of lymphoma [ Time Frame: through study completion, an average of 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04504526
|Contact: Weibing Miao, M.D.||+firstname.lastname@example.org|
|Contact: Zhenying Chenemail@example.com|
|Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University||Recruiting|
|Fuzhou, Fujian, China, 350005|
|Contact: Weibing Miao, MD +86 591 87981618 firstname.lastname@example.org|
|Contact: Zhenying Chen, MB +86 591 87981619 email@example.com|
|Principal Investigator:||Weibing Miao, M.D.||First Affiliated Hospital of Fujian Medical University|