CClinicalTrials.gg
CompletedNCT06919159Updated Apr 11, 2025

Intratumoral Heterogeneity on [18F]PSMA and [18F]FDG PET/CT in Predicting Invasion and Prognosis of Prostate Cancer

An observational study in Prostate Cancer (Diagnosis), Prostate-specific Membrane Antigen and Positron Emission Tomography (PET), sponsored by Jiequn Yu. Completed at 1 site in China. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-11.

Sponsored by Jiequn Yu · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
45
Ages
18 Years and older
Sex
Male
01

Study summary

The purpose of this study is to analyze heterogeneity of prostate cancer(PCa)based on the head-to-head imaging of prostate-specific membrane antigen (PSMA) and fluorodeoxyglucose (FDG) positron emission tomography computed tomography (PET/CT)

Read the detailed description

PET/CT examinations were performed on different days using Siemens Biograph MCT PET/CT equipment. All patients were examined on the same scanner. Patients were fasted for more than 6 h before [18F]FDG PET/CT examination, blood glucose was controlled below 11.1 mmol/L, [18F]FDG injection dose was 3.7 MBq/kg, and [18F]FDG PET/CT examination was performed after 60 min rest. [18F]PSMA-1007 injection dose was 3.7 MBq/kg, and PET/CT scan was performed 60 min after injection. To avoid interference of prostate lesion detection by active urine in the bladder, patients were asked to urinate or undergo forced diuresis before the start of the examination. The scan was performed from the top of the head to the base of the thighs. Low-dose CT was taken with automatic milliampere-second 120 kV voltage scans with a matrix of 512 × 512 and a thickness of 5 mm, and PET/CT image acquisition was taken from 5-6 beds for 2-3 min each. CT data was used for attenuation correction at the end of the acquisition, reconstructed by the two-iteration method (21 subsets in total), and the True X +TOF algorithm was applied to reconstruct the images. Two nuclear medicine physicians with extensive experience in PET/CT interpretation evaluated the images using the LIFEx software v 7.1.0. Both readers were blinded to both clinical and pathological data

02

Conditions studied

  • Prostate Cancer (Diagnosis)
  • Prostate-specific Membrane Antigen
  • Positron Emission Tomography (PET)

Keywords

  • Fluorine-18-fluorodeoxyglucose
  • Heterogeneity
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 45 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

This is the only study on the registry with Jiequn Yu as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Sampling method
Non-probability sample

Study population

Subjects treated at the First Affiliated Hospital of China Medical University

Inclusion criteria

  • Untreated patients with PCa confirmed by prostate systemic pathological biopsy
  • Patients underwent [18F]PSMA-1007 and [18F]FDG PET/CT and the imaging interval was less than one month.

Exclusion criteria

Exclusion Criteria:

  • Patients received treatment at intervals of two imaging
  • Imaging was less than 1 week after pathology biopsy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
45 participants (actual)
Patient registry
No

Groups and cohorts

  • double positive group

    patients with one type of PSMA+/FDG+ homogeneous segment

    Diagnostic Test: PSMA PET/CT scan · Diagnostic Test: FDG-PET

  • double negative group

    patients with one type of PSMA-/FDG- homogeneous segment

    Diagnostic Test: PSMA PET/CT scan · Diagnostic Test: FDG-PET

  • PSMA predominant group

    patients with one type of PSMA+/FDG- heterogeneous segment

    Diagnostic Test: PSMA PET/CT scan · Diagnostic Test: FDG-PET

  • FDG predominant group

    patients with one type of PSMA-/FDG+ heterogeneous segment

    Diagnostic Test: PSMA PET/CT scan · Diagnostic Test: FDG-PET

Interventions

  • Diagnostic testPSMA PET/CT scan

    Different developing agents

  • Diagnostic testFDG-PET

    Different developing agents

06

What researchers measure

Primary outcomes

  1. The relationship between imaging phenotypes and gleason score (GS)

    Time frame: From enrollment to the end of 1 month inspection

07

Study locations

1 site
  • Department of Nuclear Medicine, The First Hospital of China Medical University
    Shenyang, Liaoning 110001, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06919159
Lead sponsor
Jiequn Yu
Responsible party
Jiequn Yu (resident doctor, First Hospital of China Medical University) — Sponsor-investigator
First posted
Apr 9, 2025
Start date
Jul 1, 2021
Primary completion
Nov 20, 2022
Completion
Nov 30, 2022
Last update
Apr 11, 2025

Study contacts

Xuena Li, PhD
study director · First Hospital of China Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion