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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

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
18F-PSMA-1007
18F-FDG
Sponsored by
First Hospital of China Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Myeloma focused on measuring Multiple Myeloma, Prostate specific membrane antigen, fluorodeoxyglucose, positron emission tomography/Computed Tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of China Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

standardized uptake value (SUV) of myeloma lesions
comparing the SUVmax of myeloma lesions derived from 18F-PSMA-1007 and 18F-FDG PET/CT

Full Information

First Posted
July 3, 2022
Last Updated
July 6, 2022
Sponsor
First Hospital of China Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05448404
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Hospital of China Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Prostate specific membrane antigen, fluorodeoxyglucose, positron emission tomography/Computed Tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
18F-PSMA-1007 PET/CT and 18F-FDG PET/CT Imaging completed within one week in the same patients.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
18F-PSMA-1007 and 18F-FDG PET/CT scan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
18F-PSMA-1007
Other Intervention Name(s)
18F-PSMA-1007 injection
Intervention Description
Intravenous injection of dosage of 222-370MBq(6-10mCi) 18F-PSMA-1007.
Intervention Type
Drug
Intervention Name(s)
18F-FDG
Other Intervention Name(s)
18F-FDG injection
Intervention Description
Intravenous injection of dosage of 222-370MBq(6-10mCi) 18F-FDG.
Primary Outcome Measure Information:
Title
number of myeloma lesions
Description
comparing the number of myeloma lesions detected by 18F-PSMA-1007 and 18F-FDG PET
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
standardized uptake value (SUV) of myeloma lesions
Description
comparing the SUVmax of myeloma lesions derived from 18F-PSMA-1007 and 18F-FDG PET/CT
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuena Li, MD
Phone
86-13516035756
Email
lixuenacmunm@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ling Xu, MM
Phone
86-18752118670
Email
xzmcxl@163.com
Facility Information:
Facility Name
The First Affiliated Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuena Li, MD
Phone
86-13516035756
Email
lixuenacmunm@163.com
First Name & Middle Initial & Last Name & Degree
Ling Xu, MM
Phone
86-18752118670
Email
xzmcxl@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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