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Not yet recruiting NCT07510906

Evaluation of a Prostate-Targeted PET Imaging System (P-PET) for Detecting Prostate Cancer

No phase Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prostate-Targeted PET- Scan (P-PET)..
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: No limits · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Pilot Study to Evaluate the Imaging Capability of a Novel Prostate-targeted PET System (P-PET) to Detect Prostate Cancer

Overview

The goal of this study is to evaluate the imaging capabilities of a new prostate-targeted PET system (P-PET) and determine whether it could be useful in detecting prostate cancer by comparing SOC whole body PET imaging. This pilot study will include adult men who have been diagnosed with or are suspected to have prostate cancer. Participants will undergo a standard-of-care PET/CT scan followed by an additional P-PET scan designed to provide detailed images of the prostate. The images from the two scans to assess how well the P-PET system can detect prostate cancer.

Detailed description

This pilot study will evaluate the performance of a novel prostate-targeted positron emission tomography (PET) imaging system (P-PET) in men undergoing PET imaging for primary staging of prostate cancer. This study is designed to assess the feasibility and diagnostic performance of this new imaging approach.

Participants will receive the standard-of-care PET radiotracer fluroine-18 PSMA-1007 (18F-PSMA-1007) as part of routine clinical PET imaging. While the tracer is circulating in the body, a research dynamic imaging sequence will be performed, followed by the standard-of-care whole body PET scan. Immediately after completion of the standard imaging, participants will undergo the research P-PET scan during the same imaging visit. No additional radiotracer will be administered for the P-PET scan, as it used the same tracer injection given for the standard-of-care PET imaging.

Images obtained from the P-PET system will undergo comparative analysis with the standard-of-care PET scan images to assess lesion detection, image quality and overall imaging performance. The findings from this study will provide preliminary data on feasibility and potential diagnostic value of the P-PET system and may guide future research in prostate-targeted PET imaging.

Interventions

  • Diagnostic test Prostate-Targeted PET- Scan (P-PET).
    Participants will undergo a prostate-targeted PET scan to detect prostate cancer. This research scan is performed after the standard-of-care PET scan to evaluate its imaging capability. While the radioisotope is still active.

Primary outcome measures

  • Qualitative comparison of PET scans acquired by the P-PET vs. WB PET [Time frame: Baseline (Day1)]
Secondary outcome measures (1)
  • Number of Prostate Lesions Detected by P-PET Compared with Standard-of-care Whole-Body PET [Time frame: Baseline (Day 1)]

Eligibility criteria

Inclusion criteria

  • Qualitative comparison of PET scans acquired by the P-PET vs. WB PET

Exclusion criteria

  • Unable to comply with the length of scan time due to the study imaging.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Canada · 1 center
  • St. Joseph Health Care London — London

Identifiers

NCT: NCT07510906 · 15142

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗