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

NCT ID: NCT06919159

Last Updated: 2025-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-11-30

Brief Summary

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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)

Detailed Description

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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

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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double positive group

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

PSMA PET/CT scan

Intervention Type DIAGNOSTIC_TEST

Different developing agents

FDG-PET

Intervention Type DIAGNOSTIC_TEST

Different developing agents

double negative group

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

PSMA PET/CT scan

Intervention Type DIAGNOSTIC_TEST

Different developing agents

FDG-PET

Intervention Type DIAGNOSTIC_TEST

Different developing agents

PSMA predominant group

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

PSMA PET/CT scan

Intervention Type DIAGNOSTIC_TEST

Different developing agents

FDG-PET

Intervention Type DIAGNOSTIC_TEST

Different developing agents

FDG predominant group

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

PSMA PET/CT scan

Intervention Type DIAGNOSTIC_TEST

Different developing agents

FDG-PET

Intervention Type DIAGNOSTIC_TEST

Different developing agents

Interventions

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PSMA PET/CT scan

Different developing agents

Intervention Type DIAGNOSTIC_TEST

FDG-PET

Different developing agents

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Jiequn Yu

OTHER

Sponsor Role lead

Responsible Party

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Jiequn Yu

resident doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xuena Li, PhD

Role: STUDY_DIRECTOR

First Hospital of China Medical University

Locations

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Department of Nuclear Medicine, The First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

Countries

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China

Other Identifiers

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[2020]388

Identifier Type: -

Identifier Source: org_study_id

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