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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA252311 | U.S. NIH Grant/Contract | View source | |
| JT 18100 | Other Identifier | JeffTrial Number |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVES:
I. To collect multiparametric ultrasound (mp-US) data on 70 patients within 30 days of their radical prostatectomy.
II. To correlate the imaging data with whole mount prostatectomy specimens in order to optimize mp-US with a machine learning approach.
OUTLINE:
Patients receive perflutren lipid microspheres intravenously (IV) over 5-6 minutes and undergo ultrasound over 30 minutes. Patients may receive up to 2 additional doses of perflutren lipid microspheres during ultrasound.
After completion of study, patients are followed up for 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (perflutren lipid microspheres, ultrasound) | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perflutren Lipid Microspheres | Drug | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Multiparametric ultrasound (mp-US) data to identify sites of significant malignancy within the prostate | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States | ||
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 6, 2026 | Jun 30, 2026 | 10 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C042852 | perflutren |
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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| Ultrasound | Procedure | Undergo ultrasound |
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| Amsterdam University Medical Centers |
| Amsterdam |
| Netherlands |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D055585 |
| Physical Phenomena |