68Ga-PSMA PET/CT Imaging in Assessment of Prostate Cancer

IMAGE Clinical Trial

Official title:

68Ga-PSMA PET/CT Imaging in Assessment of PCa: Feasibility of Delayed Acquisition on Total-body PET/CT Scanner?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05134064
• Other study ID #: 2018-104
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: November 2021
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Dual-time point 68Ga-PSMA PET/CT could increase the lesion detection in PCa patients, it remains difficult to perform in clinical practice. The possibility of one-time point 68Ga-PSMA PET/CT imaging could be achieved using a total-body PET/CT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• primary staging of pathology-confirmed PCa or evidence of BCR with PSA value > 0.2 ng/ml
• positive 68Ga-PSMA findings
• both standard and delayed scans were performed on the total-body PET/CT

Exclusion Criteria:

• only one scan was performed
• negative PSMA results

Related Conditions & MeSH terms

• IMAGE
• PET/CT

Intervention

Device:
• total-body PET/CT
PCa patients who underwent PSMA PET/CT in our clinical center received two-time points scans at 1 h p.i. and 3 h p.i. on a total-body PET/CT scanner.

Locations

Country	Name	City	State
China	Shanghai jiaotong University School of Medicine, Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Only one-time point scan is possible for PSMA PET/CT	By the use of total- body PET/CT scanner, the imaging quality between the 1 h p.i. and 3 h p.i. imaging acquisition are compared. And the different lesion detection rates at 3 h p.i. and 1 h p.i. are also discussed. The uptake value differences of all lesions are compared.	8 months