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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


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Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

First Hospital of China Medical University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries China

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Additional Details

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.

Arms & Interventions


Experimental: 18F-PSMA-1007 and 18F-FDG PET/CT scan

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

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

Drug: - 18F-FDG

Intravenous injection of dosage of 222-370MBq(6-10mCi) 18F-FDG.

Contact a Trial Team

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International Sites

Shenyang, Liaoning, China




The First Affiliated Hospital of China Medical University

Shenyang, Liaoning,

Site Contact

Xuena Li, MD