NCT06387381

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
8mo left

Started May 2024

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
May 2024Dec 2026

First Submitted

Initial submission to the registry

April 24, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
21 days until next milestone

Study Start

First participant enrolled

May 20, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

April 24, 2024

Last Update Submit

May 29, 2025

Conditions

PSMAFAPPositron-Emission Tomography

Outcome Measures

Primary Outcomes (1)

  • Diagnostic efficacy

    The sensitivity, specificity, and accuracy of 68Ga-PSFA PET

    15 days

Study Arms (1)

68Ga-PSFA

EXPERIMENTAL

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

Drug: 68Ga-PSFA

Interventions

68Ga-PSFADRUG

Each subject receives a single intravenous injection of 68Ga-PSFA.

68Ga-PSFA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39520516DERIVED

Central Study Contacts

Xiaoyang Zhang, PhD

CONTACT

86 023-89011755zhangxy@mail.bnu.edu.cn

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 24, 2024

First Posted

April 29, 2024

Study Start

May 20, 2024

Primary Completion

April 30, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

June 4, 2025

Record last verified: 2025-05

Locations

CN(1)