Clinical trial NCT03436342: Chemokine Receptor CXCR4-targeting Molecular Imaging for Metabolic Characterization of Multiple Myeloma and Lymphoma
Official title: Chemokine Receptor CXCR4-targeting Molecular Imaging for Metabolic Characterization of Multiple Myeloma and Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Multiple Myeloma
Lymphoma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Chemokine receptor CXCR4 was expressed in MM and lymphoma cells and CXCR4-targeting molecular imaging- 68Ga-Pentixafor PET/CT could be a promising technique to evaluate the extent of MM and lymphoma with higher accuracy. This prospective study is going to investigate whether metabolic characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, risk stratification, and prognostic evaluation of MM and lymphoma.

Detailed description: Multiple myeloma:

Multiple myeloma (MM) is characterized by the neoplastic proliferation of plasma cells producing a monoclonal immunoglobulin. The Durie and Salmon and ISS clinical staging system have been well-accepted as a practical way to evaluate MM tumor burden nowadays. But it is difficult to assess the accurate tumor involvement because of the significant heterogeneity characterizing this disease at multiple levels such as clinical presentation, biologic characteristics, treatment response, and clinical outcome. New imaging modalities such as 18F-FDG PET/CT has been used to improve the efficacy of this system in assessing the extent and severity of MM, but the diagnostic accuracy of 18F-FDG PET/CT decreased in lower proliferative MM cells and inflammation. Recent 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 whether metabolic characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, risk stratification, and prognostic evaluation of MM.

Lymphoma:

Lymphoma is a frequent cancer with high CXCR4 expression. According to the previous studies, 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，differentiation and pretherapeutic evaluation of CXCR4 expression in lymphoma.

Eligibility criteria: Inclusion criteria：

* suspected or confirmed untreated MM or lymphoma patients
* 18F-FDG PET/CT within two weeks
* signed written consent.

Exclusion criteria:

* pregnancy
* breastfeeding
* known allergy against Pentixafor
* any medical condition that in the opinion of the investigator,may significantly interfere with study compliance.

Primary outcomes:
measure: SUVmax
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Diagnostic value
timeFrame: through study completion, an average of 2 years
measure: Incidence of emergency events during the study
timeFrame: through study completion, an average of 2 years
measure: Tumor burden assessement
timeFrame: through study completion, an average of 2 years
measure: Diagnostic value in special type of multiple myeloma
timeFrame: through study completion, an average of 2 years
measure: CXCR4 expression and SUV
timeFrame: through study completion, an average of 2 years
measure: Overall Survival
timeFrame: 1 year and 5 years after been diagnosed
measure: Disease Free Survival
timeFrame: 1 year and 5 years after been diagnosed
measure: Disease Specific Survival
timeFrame: 1 year and 5 years after been diagnosed
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science
Study officials:
affiliation: Peking Union Medical College Hospital
name: Fang Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pan Q, Cao X, Luo Y, Li J, Feng J, Li F. Chemokine receptor-4 targeted PET/CT with 68Ga-Pentixafor in assessment of newly diagnosed multiple myeloma: comparison to 18F-FDG PET/CT. Eur J Nucl Med Mol Imaging. 2020 Mar;47(3):537-546. doi: 10.1007/s00259-019-04605-z. Epub 2019 Nov 27.