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NCT05448404 Clinical Trial

A Head-to-head Comparative Study of 18F-PSMA-1007 PET/CT and 18F-FDG PET/CT Imaging in Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:
A Head-to-head Comparative Study of 18F-PSMA-1007 PET/CT and 18F-FDG PET/CT Imaging in Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05448404
Other study ID # 37587411
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 8, 2022
Est. completion date June 30, 2023

Study information
Verified date July 2022
Source First Hospital of China Medical University
Contact Xuena Li, MD
Phone 86-13516035756
Email lixuenacmunm@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Multiple myeloma (MM) is the second most common hematological malignancy and is still incurable. Positron emission tomography/computed tomography (PET/CT) has been used to diagnose, assess treatment response, and predict prognosis in MM. 18F-fluorodeoxyglucose (FDG) is the most widely used radiotracer, but there is heterogeneous uptake in MM, that is, uptake is negative in some myeloma cells. There are currently reports of cases with strong uptake of prostate-specific membrane antigen (PSMA) PET/CT in MM. Therefore, this preliminary study was designed to compare the imaging results of 18F-PSMA-1007 PET/CT and 18F-FDG PET/CT, and to evaluate the additional value of 18F-PSMA-1007 PET/CT to 18F-FDG PET/CT in MM.

Description:

18F-fluorodeoxyglucose (FDG) PET/CT can identify bone lesions, assess disease burden, and detect extramedullary lesions in multiple myeloma(MM), but due to MM is a complex and heterogeneous disease , 18F-FDG PET/CT has heterogeneous uptake in MM bone lesions, resulting in false negative results in the diagnosis of MM bone disease, then affecting the diagnosis, staging and evaluation of the response to treatment of MM. Prostate-specific membrane antigen (PSMA) is a specific membrane-bound glycoprotein, recently high uptake in PSMA PET/CT in MM bone lesions has been published in case reports, thus PSMA PET CT imaging may have potential value for multiple myeloma. There are no head-to-head studies comparing 18F-PSMA-1007 PET/CT with 18F-FDG PET/CT in multiple myeloma. Therefore, this study intends to compare the detection rate of lesions by 18F-PSMA-1007 PET/CT and 18F-FDG PET/CT in MM , and to evaluate the additional value of 18F-PSMA-1007 PET/CT to 18F-FDG PET/CT in multiple myeloma.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date June 30, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - confirmed untreated or relapsed multiple myeloma patients; - 18F-PSMA-1007 and 18F-FDG PET/CT within one week; - signed written consent; - no combined other Malignant tumors. Exclusion Criteria: - suffered from arthritis or combined with other malignant tumors; - received myeloma-related therapy within 3 months before PET/CT imaging - any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 18F-PSMA-1007
Intravenous injection of dosage of 222-370MBq(6-10mCi) 18F-PSMA-1007.
• 18F-FDG
Intravenous injection of dosage of 222-370MBq(6-10mCi) 18F-FDG.

Locations
Country Name City State
China The First Affiliated Hospital of China Medical University Shenyang Liaoning

Sponsors (1)
Lead Sponsor Collaborator
First Hospital of China Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of myeloma lesions comparing the number of myeloma lesions detected by 18F-PSMA-1007 and 18F-FDG PET through study completion, an average of 1 year
Secondary standardized uptake value (SUV) of myeloma lesions comparing the SUVmax of myeloma lesions derived from 18F-PSMA-1007 and 18F-FDG PET/CT through study completion, an average of 1 year
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