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

NCT05134064 | Completed FDA Device

• 1 other identifier: 2018-104
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PET/CT; Prostate Specific Membrane Antigen; IMAGE

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

PCa patients underwent 1 h p.i. PSMA PET/CT imaging and 3 h p.i. PSMA imaging

Device: total-body PET/CT

Interventions

total-body PET/CT DEVICE

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.

PCa patients underwent 1 h p.i. PSMA PET/CT imaging and 3 h p.i. PSMA imaging

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The prospective study consisted of 56 patients for 68Ga-PSMA-11 total-body PET/CT examination between December 2020 and July 2021.

You may qualify if:

• 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

You may not qualify if:

• only one scan was performed
• negative PSMA results

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Shanghai jiaotong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: deputy head of the department of nuclear medicine

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 24, 2021
• Study Start: December 1, 2020
• Primary Completion: July 31, 2021
• Study Completion: August 31, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)