Detecting clinically significant prostate cancer with advanced MRI microstructure mapping and detailed tissue comparison
Bridging Imaging and Pathology: Using Advanced MRI Protocols in Correlation With Extensive Histopathology to Detect Clinically Significant Prostate Cancer
Virdx, Inc. · NCT07432360
This project will try advanced MRI scans that map prostate tissue microstructure together with detailed pathology to see if they better identify clinically significant prostate cancer in men scheduled for prostate removal.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Virdx, Inc. (industry) |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT07432360 on ClinicalTrials.gov |
What this trial studies
The project uses additional, non-routine MRI sequences to generate mathematical microstructure models that estimate proportions of tissue substructures within the prostate. Multiple competing microstructure models will be calculated from these advanced MRI acquisitions and directly compared. Prostatectomy specimens will undergo extensive histopathological analysis to serve as the reference standard for imaging findings. The goal is to determine which MRI protocols and models most accurately match the tissue-level diagnosis of clinically significant cancer.
Who should consider this trial
Good fit: Men aged 18 or older with biopsy-proven prostate cancer who are scheduled for radical prostatectomy and can safely undergo MRI are the intended participants.
Not a fit: Patients who have had prior prostate treatments, hormonal therapy, prostate surgery, incompatible metal implants, or any contraindication to MRI are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could help doctors detect aggressive prostate cancers more accurately and reduce unnecessary biopsies or treatments.
How similar studies have performed: Other research into MRI microstructure and advanced diffusion models has shown promising but still emerging results, so this approach builds on encouraging but not yet definitive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Humans with a prostate ≥18 years of age. * Patients with biopsy-proven PCa who are scheduled for an RPE. * Signed informed consent form (ICF) that demonstrates study participant understands the purpose of and procedures necessary for the study. * Willingness, ability, and legal capacity to participate in the study. * Ability to adhere to the prohibitions and restrictions defined in this protocol. Exclusion Criteria: * Inability to give consent. * Prior hormone treatment (i.e., androgen deprivation treatment (ADT) and/or 5-ɑ-reductase inhibitors). * Prior PCa treatment. * Prior transurethral resection of the prostate (TUR-P) or other prostate surgery. * Prior total hip arthroplasty on one or both sides or other metal implants that interfere with the MRI acquisition of the hip region. * General contraindications for an MRI scan (i.e., pacemaker, relevant metal implants, etc.).
Where this trial is running
São Paulo
- Instituto do Câncer do Estado de São Paulo — São Paulo, Brazil (RECRUITING)
Study contacts
- Principal investigator: Marcelo Araujo Queiroz, MD PhD — Instituto do Câncer do Estado de São Paulo
- Study coordinator: Sina Knapp, PhD
- Email: sina.knapp@virdx.com
- Phone: +4917680891277
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer