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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: 18F-PSMA-1007
* Drug: 18F-FDG


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: 18F-PSMA-1007 PET/CT and 18F-FDG PET/CT Imaging completed within one week in the same patients.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-PSMA-1007 and 18F-FDG PET/CT scan<br>Patients of multiple myeloma PET/CT imaging: Within one week each patient underwent a PET/CT scan 60-min after intravenous administration of 18F-PSMA-1007 and 18F-FDG, respectively. | Drug: 18F-PSMA-1007<br>* Intravenous injection of dosage of 222-370MBq(6-10mCi) 18F-PSMA-1007.<br>* Other names: 18F-PSMA-1007 injection;Drug: 18F-FDG<br>* Intravenous injection of dosage of 222-370MBq(6-10mCi) 18F-FDG.<br>* Other names: 18F-FDG injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, Prostate specific membrane antigen, fluorodeoxyglucose, positron emission tomography/Computed Tomography