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

April 9, 2025 updated by: Jiequn Yu

Intratumoral Heterogeneity on [18F]PSMA-1007 and [18F]FDG PET/CT in Predicting Invasion and Prognosis of Primary Prostate Cancer

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Subjects treated at the First Affiliated Hospital of China Medical University

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
double positive group
patients with one type of PSMA+/FDG+ homogeneous segment
Diagnostic test: PSMA PET/CT scan
Different developing agents
Diagnostic test: FDG-PET
Different developing agents
double negative group
patients with one type of PSMA-/FDG- homogeneous segment
Diagnostic test: PSMA PET/CT scan
Different developing agents
Diagnostic test: FDG-PET
Different developing agents
PSMA predominant group
patients with one type of PSMA+/FDG- heterogeneous segment
Diagnostic test: PSMA PET/CT scan
Different developing agents
Diagnostic test: FDG-PET
Different developing agents
FDG predominant group
patients with one type of PSMA-/FDG+ heterogeneous segment
Diagnostic test: PSMA PET/CT scan
Different developing agents
Diagnostic test: FDG-PET
Different developing agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The relationship between imaging phenotypes and gleason score (GS)
Time Frame: From enrollment to the end of 1 month inspection
From enrollment to the end of 1 month inspection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiequn Yu

Investigators

  • Study Director: Xuena Li, PhD, First Hospital of China Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

November 20, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

April 2, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

April 11, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2020]388

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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