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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

Sponsor
First Hospital of China Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05448404
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
15.7
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
18F-PSMA-1007 PET/CT and 18F-FDG PET/CT Imaging completed within one week in the same patients.18F-PSMA-1007 PET/CT and 18F-FDG PET/CT Imaging completed within one week in the same patients.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Head-to-head Comparative Study of 18F-PSMA-1007 PET/CT and 18F-FDG PET/CT Imaging in Multiple Myeloma
Actual Study Start Date :
Mar 8, 2022
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
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.
Other Names:
  • 18F-PSMA-1007 injection

    • Drug: 18F-FDG
    Intravenous injection of dosage of 222-370MBq(6-10mCi) 18F-FDG.
    Other Names:
  • 18F-FDG injection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. number of myeloma lesions [through study completion, an average of 1 year]

      comparing the number of myeloma lesions detected by 18F-PSMA-1007 and 18F-FDG PET

    Secondary Outcome Measures

    1. standardized uptake value (SUV) of myeloma lesions [through study completion, an average of 1 year]

      comparing the SUVmax of myeloma lesions derived from 18F-PSMA-1007 and 18F-FDG PET/CT

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital of China Medical University Shenyang Liaoning China

    Sponsors and Collaborators

    • First Hospital of China Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xuena Li, Director, First Hospital of China Medical University
    ClinicalTrials.gov Identifier:
    NCT05448404
    Other Study ID Numbers:
    • 37587411
    First Posted:
    Jul 7, 2022
    Last Update Posted:
    Jul 8, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xuena Li, Director, First Hospital of China Medical University
    Multiple Myeloma
    Prostate specific membrane antigen
    fluorodeoxyglucose
    positron emission tomography/Computed Tomography
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Fluorodeoxyglucose F18

    Study Results

    No Results Posted as of Jul 8, 2022