Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05448404
Enrollment
30
Registered
2022-07-07
Start date
2022-03-08
Completion date
2023-06-30
Last updated
2022-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma, Prostate specific membrane antigen, fluorodeoxyglucose, positron emission tomography/Computed Tomography

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.

Interventions

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

DRUG18F-FDG

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

Sponsors

First Hospital of China Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

18F-PSMA-1007 PET/CT and 18F-FDG PET/CT Imaging completed within one week in the same patients.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
number of myeloma lesionsthrough study completion, an average of 1 yearcomparing the number of myeloma lesions detected by 18F-PSMA-1007 and 18F-FDG PET

Secondary

MeasureTime frameDescription
standardized uptake value (SUV) of myeloma lesionsthrough study completion, an average of 1 yearcomparing the SUVmax of myeloma lesions derived from 18F-PSMA-1007 and 18F-FDG PET/CT

Countries

China

Contacts

Primary ContactXuena Li, MD
lixuenacmunm@163.com86-13516035756
Backup ContactLing Xu, MM
xzmcxl@163.com86-18752118670

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026