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OpenTrials
Completed

NCT Number: NCT06919159

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

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Key information

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PSMA PET/CT scan

Diagnostic Test

Different developing agents

FDG-PET

Diagnostic Test

Different developing agents

Primary outcomes

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

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

Sponsors and collaborators

Lead sponsor

Jiequn Yu

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 9, 2025
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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