A Head-to-head Comparative Study of 18F-PSMA-1007 PET/CT... | NCT05448404

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

NCT05448404

Sponsor

First Hospital of China Medical University

Status

Unknown status

Last Update Posted

Jul 8, 2022Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Multiple Myeloma

Interventions

18F-PSMA-1007
18F-FDG

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 8, 2022Actual

Primary Completion Date

May 31, 2023Estimated

Completion Date

Jun 30, 2023Estimated

First Submitted Date

Jul 3, 2022

First Submission Date that Met QC Criteria

Jul 3, 2022

First Posted Date

Jul 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2022

Last Update Posted Date

Jul 8, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xuena Li, Director, First Hospital of China Medical UniversityPrincipal Investigator

Lead Sponsor

First Hospital of China Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
18F-PSMA-1007 and 18F-FDG PET/CT scan	Experimental	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 Drug: 18F-FDG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18F-PSMA-1007	Drug	Intravenous injection of dosage of 222-370MBq(6-10mCi) 18F-PSMA-1007.	18F-PSMA-1007 and 18F-FDG PET/CT scan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
standardized uptake value (SUV) of myeloma lesions	comparing the SUVmax of myeloma lesions derived from 18F-PSMA-1007 and 18F-FDG PET/CT	through study completion, an average of 1 year

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xuena Li, MD	Contact	86-13516035756		lixuenacmunm@163.com
Ling Xu, MM	Contact	86-18752118670		xzmcxl@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of China Medical University	Recruiting	Shenyang	Liaoning		China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019788	Fluorodeoxyglucose F18

Ancestor Terms

ID	Term
D003847	Deoxyglucose
D003837	Deoxy Sugars
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided