68Ga-PSFA PET Imaging in Patients With PSMA/FAP Positive... | NCT06387381

Studies
68Ga-PSFA PET Imaging in Patients With PSMA/FAP Positive Disease

NCT06387381

Sponsor

First Affiliated Hospital of Chongqing Medical University

Status

Recruiting

Last Update Posted

Jun 4, 2025Actual

Enrollment

30Estimated

Phase

Early Phase 1

Conditions

PSMA
FAP
Positron-Emission Tomography

Interventions

68Ga-PSFA

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

May 2025

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

May 20, 2024Actual

Primary Completion Date

Apr 30, 2025Actual

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Apr 24, 2024

First Submission Date that Met QC Criteria

Apr 24, 2024

First Posted Date

Apr 29, 2024Actual

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

May 29, 2025

Last Update Posted Date

Jun 4, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaoyang Zhang, Principal Investigator, First Affiliated Hospital of Chongqing Medical UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital of Chongqing 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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

As a new dual receptor (PSMA and FAP) targeting PET radiotracer, 68Ga-PSFA is promising as an excellent imaging agent applicable to PSMA/FAP positive diseases. In this research, we investigate the safety, biodistribution and potential usefulness of 68Ga-PSFA positron emission tomography (PET) for the diagnosis of lesions in PSMA/FAP positive diseases.

Detailed Description

Not provided

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

Early Phase 1

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
68Ga-PSFA	Experimental	Patients will receive a single administration of 68Ga-PSFA.	Drug: 68Ga-PSFA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
68Ga-PSFA	Drug	Each subject receives a single intravenous injection of 68Ga-PSFA.	68Ga-PSFA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic efficacy	The sensitivity, specificity, and accuracy of 68Ga-PSFA PET	15 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least 18 years of age.
Signed informed consent.
Patients with suspected or newly diagnosed or previously malignant disease, with either PSMA or FAP positive expression (supporting evidence may include MRI, CT, and pathology report, etc).

Exclusion Criteria:

Patients with non-malignant disease.
Patients with pregnancy.
The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Known or expected hypersensitivity to 68Ga-PSFA or any of its components.
Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.

Accepts Healthy Volunteers

Yes

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
Xiaoyang Zhang, PhD	Contact	86 023-89011755		zhangxy@mail.bnu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Chongqing Medical University	Recruiting	Chongqing	Chongqing Municipality	400016	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39520516	Derived	Wang X, Zhang X, Zhang X, Guan L, Gao X, Xu L, Pang H, Du J, Zhang J, Cui M. Design, preclinical evaluation, and first-in-human PET study of [68Ga]Ga-PSFA-01: a PSMA/FAP heterobivalent tracer. Eur J Nucl Med Mol Imaging. 2025 Feb;52(3):1166-1176. doi: 10.1007/s00259-024-06965-7. Epub 2024 Nov 9.