Clinical trial · Interventional
Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase III trial investigates if perflutren lipid microspheres with ultrasound can be used to diagnose prostate cancer non-invasively. Definity (perflutren lipid microspheres) is an ultrasound contrast agent that is typically used for ultrasound bubble studies that involve the heart. Definity appears on ultrasound images as tiny gas-filled microbubbles. These microbubbles are about the size of a red blood cell and do not stay in a patient's body for more than several minutes, where they are excreted from the lungs and exhaled back into the air when breathing. Definity may enhance ultrasound images of the prostate and help doctors identify prostate cancer on ultrasound images.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Perflutren Lipid Microspheres | Drug | — | UNRESOLVED |
| Ultrasound | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (perflutren lipid microspheres, ultrasound)
- description
- Patients receive perflutren lipid microspheres IV over 5-6 minutes and undergo ultrasound over 30 minutes. Patients may receive up to 2 additional doses of perflutren lipid microspheres
- interventionNames
- Drug: Perflutren Lipid Microspheres
- Procedure: Ultrasound
Primary outcomes (1)
- measure
- Multiparametric ultrasound (mp-US) data to identify sites of significant malignancy within the prostate
- timeFrame
- Up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject must be scheduled for radical prostatectomy for treatment of prostate cancer * Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate prior to prostatectomy * Subject must be a male at least 18 years of age when informed consent is obtained Exclusion Criteria: * Participant in a clinical trial involving an investigational drug within the past 30 days * Patients with known or suspected hypersensitivity to perflutren, PEG, or any other component of Definity * Previous treatment for prostate cancer, including hormone therapy * Clinically unstable, severely ill, or moribund as per treating physician
References
Publications (0)
Data not yet available