Application of 18F-PSMA PET / CT Imaging in Prostate Spec... | NCT05761366

Studies
Application of 18F-PSMA PET / CT Imaging in Prostate Specific Membrane Antigen Positive Tumor

NCT05761366

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Status

Recruiting

Last Update Posted

Dec 27, 2024Actual

Enrollment

400Estimated

Phase

Phase 2

Conditions

Malignancy

Interventions

Al18F-PSMA-BCH PET/CT

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

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 13, 2022Actual

Primary Completion Date

Oct 13, 2025Estimated

Completion Date

Oct 13, 2025Estimated

First Submitted Date

Feb 19, 2023

First Submission Date that Met QC Criteria

Mar 7, 2023

First Posted Date

Mar 9, 2023Actual

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

Dec 21, 2024

Last Update Posted Date

Dec 27, 2024Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study, Al18F-PSMA-BCH PET/CT will be performed in patients with prostate specific membrane antigen positive tumor, to evaluate the tumour detection efficacy of Al18F-PSMA-BCH PET/CT.

Detailed Description

Al18F-PSMA-BCH PET/CT will be performed on patients with suspected or clearly diagnosed PSMA positive-expressing tumors (including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.) , to evaluate the tumour detection efficacy of Al18F-PSMA-BCH PET/CT.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Al18F-PSMA-BCH PET/CT	Experimental	Al18F-PSMA-BCH PET/CT will be performed on patients with suspected or clearly diagnosed PSMA positive-expressing tumors.（including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.）	Drug: Al18F-PSMA-BCH PET/CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Al18F-PSMA-BCH PET/CT	Drug	Patients will be intravenously injected with Al18F-PSMA-BCH and undergo PET/CT scan.	Al18F-PSMA-BCH PET/CT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic value	Sensitivity and Specificity of 18F-PSMA PET / CT for the diagnosis of Prostate Specific Membrane Antigen Positive Tumor	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with suspected or clearly diagnosed PSMA positive-expressing tumors, including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.
Age is 18 or older; No gender limitation.
Signed the informed consent.
Willing and able to cooperate with all projects in this study.

Exclusion Criteria:

Patients with serious neurological diseases,or gastrointestinal tract disease, cardiovascular disease, liver disease, kidney disease, blood system disease, endocrine system disease, respiratory system disease, immune deficiency disease, etc
Claustrophobia.
Pregnant or lactation women.
Received experimental drug or device within 1 month.

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
Xin Cheng, MD	Contact	15120002998		cxpumc@foxmail.com
Guozhu Hou, MD	Contact	15611145656		15611145656@163.com

Overall Officials

Name	Affiliation	Role
Rong Zheng, MD	National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and PUMC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College	Recruiting	Beijing	Chaoyang	100029	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided