Prostate Specific Membrane Antigen PET/CT Imaging in PSMA-Related Disease Patients

NCT06690970 | Recruiting

• 1 other identifier: TJMUGH-04
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the potential usefulness of 68Ga/18F-PSMA/PSFA positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various PSMA-related disease patients.

Conditions

PSMA-related Disease; Prostate Cancer; Positron Emission Tomography; Metastasis; FAP

Keywords

PET/CT; PSMA; FAP

Outcome Measures

Primary Outcomes (1)

• Standardized uptake value (SUV)

  Standardized uptake value (SUV) of PSMA for each target lesion of subject or suspected primary tumor or/and metastasis.

  30 days

Secondary Outcomes (1)

• Diagnostic efficacy

  30 days

Study Arms (1)

Single Group Assignment

Each subject receive a single intravenous injection of 68Ga/18F-PSMA/PSFA, and undergo PET/CT imaging within the specificed time.

Diagnostic Test: 68Ga/18F-PSMA/PSFA

Interventions

68Ga/18F-PSMA/PSFA DIAGNOSTIC_TEST

Each subject receive a single intravenous injection of 68Ga/18F-PSMA/PSFA, and undergo PET/CT imaging within the specificed time.

Single Group Assignment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

(i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled PSMA PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

You may qualify if:

• \- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled PSMA PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

You may not qualify if:

• \- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Sponsors & Collaborators

• Tianjin Medical University: lead
• Tianjin Medical University General Hospital: collaborator

Study Sites (2)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, 230000, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

Related Publications (1)

• Wang X, Wang M, Chen Y, Jian R, Yu H, Zhang X, Zhang J, Yao S, Du J, Cui M. Preclinical evaluation and first-in-human study of 68Ga- and Al18F-Labeled PSMA/FAP bispecific tracers for prostate cancer imaging. Eur J Nucl Med Mol Imaging. 2025 Oct 22. doi: 10.1007/s00259-025-07591-7. Online ahead of print.

  PMID: 41120594 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Haonan Yu, MD

CONTACT

+8613821000597; dreamadam@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 15, 2024
• Study Start: September 1, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)