Chemokine Receptor CXCR4-targeting Molecular Imaging for Metabolic Characterization of Multiple Myeloma and Lymphoma

Multiple Myeloma Clinical Trial

Official title:

Chemokine Receptor CXCR4-targeting Molecular Imaging for Metabolic Characterization of Multiple Myeloma and Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03436342
• Other study ID #: PekingUMCHCXCR4
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: June 2019
• Source: Peking Union Medical College Hospital
• Contact: Fang Li, M.D.
• Phone: 86-10-69155502
• Email: lifang[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• 68Ga-Pentixafor
Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-Pentixafor. Tracer doses of 68Ga-Pentixafor will be used to image lesions of MM and lymphoma by PET/CT.

Locations

Country	Name	City	State
China	Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SUVmax	SUVmax of focal lesions are measured on 68Ga-Pentixafor PET/CT. The SUVmax of the L3 vertebra is defined as the general marrow activity on the condition that there is no focally hypermetabolic disease.	through study completion, an average of 2 years
Secondary	Diagnostic value	Diagnostic value of 68Ga-Pentixafor PET/CT for MM and lymphoma in comparison with 18F-FDG PET/CT.	through study completion, an average of 2 years
Secondary	Incidence of emergency events during the study	Incidence of emergency events during the study	through study completion, an average of 2 years
Secondary	Tumor burden assessement	Correlation between tumor burden assessed on 68Ga-Pentixafor PET/CT and the DS and ISS clinical staging system for MM.	through study completion, an average of 2 years
Secondary	Diagnostic value in special type of multiple myeloma	Diagnostic value of 68Ga-Pentixafor PET/CT in monoclonal gammopathy of unknown significance (MGUS) and smoldering multiple myeloma (SMM) from symptomatic MM.	through study completion, an average of 2 years
Secondary	CXCR4 expression and SUV	Correlation between CXCR4 expression and SUV in PET	through study completion, an average of 2 years
Secondary	Overall Survival	analysis of OS for patients receiving 68Ga-Pentixafor PET/CT	1 year and 5 years after been diagnosed
Secondary	Disease Free Survival	analysis of DFS for patients receiving 68Ga-Pentixafor PET/CT	1 year and 5 years after been diagnosed
Secondary	Disease Specific Survival	analysis of DSS for patients receiving 68Ga-Pentixafor PET/CT	1 year and 5 years after been diagnosed