Stratagen Quantitative Prostate MRI Platform Pilot Study
Interventionsstudie
Phase nicht angegeben
Virginia Urology
Zuletzt aktualisiert: 6. März 2026 Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.
The goal of this clinical trial is to assess the safety and feasibility of the Stratagen Quantitative Prostate MRI Platform when used in addition to the standard scans conducted during the existing prostate MRI sessions.
* What severe problems, if any, occur because of the use of the Stratagen Quantitative Prostate MRI Platform? * Can the data collected be used to measure quantitative MRI parameters?
Participants will:
- Receive up to 15 minutes of additional MRI scan time during the existing prostate MRI imaging session.
Behandlungskategorie
Gerät
Erforderliche Mutationen
Keine
Studie gestartet
24. September 2025
Zuletzt vom Sponsor aktualisiert
6. März 2026
Voraussichtlicher Abschluss
31. März 2026
Studienkontakt
Eignung
Einschlusskriterien
* Subject has a prostate that would be considered for biopsy
* Age 40-90 years
* PSA ≥ 2.5
* Subject has been informed of the nature of the study and has provided written informed consent
Ausschlusskriterien
* Contraindication for MRI
* Prostate biopsy within the previous 12 weeks
* Implant in the pelvis that may cause artifact on MRI (e.g. hip replacement)
* History of prostatectomy or other local prostate cancer therapy (e.g., cryotherapy or brachytherapy), or previous pelvic irradiation
* Currently enrolled in another investigational drug or device study that clinically interferes with this study
* Unable to comply with the study requirements or follow up schedule
* Any condition the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the subject
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Design-Details
ZuteilungN/A
InterventionsmodellSingle Group Assignment
MaskierungNone (Open Label)
Anzahl der Teilnehmer75
Arme & Interventionen
Arme
Interventionen
Typ: Experimental
Beschreibung:
Interventionen:
MRI
Ergebnismessungen
Primäre Ergebnismessungen
Safety: no SAEs attributable to the Stratagen Quantitative Prostate MRI Platform, as determined by participating Investigator according to CTCAE guidelinesBeginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0)
All serious adverse events attributable to the Stratagen Quantitative Prostate MRI Platform will be reported.
• Feasibility: collection of the data necessary to produce measurable quantitative T1 and T2 relaxation times (milliseconds) maps (images) for at least 80% of pixels fully contained within the prostate for at least 80% of subjectsBeginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0)
Sekundäre Ergebnismessungen
Keine
Studie vormerken
Studie teilen
Studie herunterladen
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