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An Investigational Scan (18F-rhPSMA-7.3 PET-mpMRI) for Targeted Prostate Biopsy Using TRUS-MR Fusion Technique

RecruitingPhase 2Ages 18 Years - anyMaleEmory University
NCT06865768 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This phase II trial evaluates an imaging technique called 18F-rhPSMA-7.3 positron emission tomography (PET)-multiparametric (mp) magnetic resonance imaging (MRI) in identifying tumor tissue in men suspected to have prostate cancer. This clinical trial also seeks to determine if the abnormal tissue identified during imaging represents the tumor tissue removed during transrectal ultrasound-magnetic resonance imaging (TRUS-MR) fusion biopsy of the prostate. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 18F-rhPSMA-7.3. Because some tumors take up 18F-rhPSMA-7.3 it can be seen with PET. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. Stand

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male subjects aged \> 18 years * Patients with suspected prostate cancer who will have prostate biopsy for confirmation * Ability to lie still for MRI scanning * Patients must be able to provide written informed consent Exclusion Criteria: * Documented acute prostatitis, symptomatic or severe benign prostatic hyperplasia (BPH) or urinary tract infections * Patients with contraindications for MRI including implantable pace makers, cochlear implants * Patients with uni- or bilateral hip prosthesis * Subjects with other significant medical conditions that would create unacceptable prostate biopsy risk, compromise retention on study or compromise study related assessments * Prostate biopsy within 4 weeks prior to entry on this study in which inflammation might affect PET-mpMR result * Is determined by the Investigator that the patient is clinically unsuitable for the study * Is incapable of understanding the language in which the information for the patient is given * Participation in a concurrent clinical trial or in another trial within the past 30 days
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What it tests

  • Flotufolastat F-18 Gallium
  • Magnetic Resonance Imaging
  • Multiparametric Magnetic Resonance Imaging
  • Positron Emission Tomography
  • Transrectal Ultrasonography Guided Biopsy
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Where

1 site
Emory University Hospital
Atlanta, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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