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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-08

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

18F-PSMA-1007

Intervention Type DRUG

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

18F-FDG

Intervention Type DRUG

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

Interventions

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18F-PSMA-1007

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

Intervention Type DRUG

18F-FDG

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

Intervention Type DRUG

Other Intervention Names

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18F-PSMA-1007 injection 18F-FDG injection

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No