Clinical trial NCT05448404: A Head-to-head Comparative Study of 18F-PSMA-1007 PET/CT and 18F-FDG PET/CT Imaging in Multiple Myeloma
Official title: A Head-to-head Comparative Study of 18F-PSMA-1007 PET/CT and 18F-FDG PET/CT Imaging in Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Prostate specific membrane antigen
fluorodeoxyglucose
positron emission tomography/Computed Tomography
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 18F-PSMA-1007 PET/CT and 18F-FDG PET/CT Imaging completed within one week in the same patients.
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: number of myeloma lesions
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: standardized uptake value (SUV) of myeloma lesions
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
Study officials:
References: