A Head-to-head Comparative Study of 18F-PSMA-1007 PET/CT and 18F-FDG PET/CT Imaging in Multiple Myeloma
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable multiple-myeloma
Started Mar 2022
Shorter than P25 for not_applicable multiple-myeloma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 8, 2022
CompletedFirst Submitted
Initial submission to the registry
July 3, 2022
CompletedFirst Posted
Study publicly available on registry
July 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedJuly 8, 2022
July 1, 2022
1.2 years
July 3, 2022
July 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
standardized uptake value (SUV) of myeloma lesions
through study completion, an average of 1 year
Study Arms (1)
18F-PSMA-1007 and 18F-FDG PET/CT scan
EXPERIMENTALPatients 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.
Interventions
Intravenous injection of dosage of 222-370MBq(6-10mCi) 18F-PSMA-1007.
Intravenous injection of dosage of 222-370MBq(6-10mCi) 18F-FDG.
Eligibility Criteria
You may qualify if:
- confirmed untreated or relapsed multiple myeloma patients;
- F-PSMA-1007 and 18F-FDG PET/CT within one week;
- signed written consent;
- no combined other Malignant tumors.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
July 3, 2022
First Posted
July 7, 2022
Study Start
March 8, 2022
Primary Completion
May 31, 2023
Study Completion
June 30, 2023
Last Updated
July 8, 2022
Record last verified: 2022-07