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| Name | Class |
|---|---|
| Telix Pharmaceuticals (Innovations) Pty Limited | INDUSTRY |
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Illuccix will be used per the prescribing instructions for PET-CT imaging on the United Imaging scanner uEXPLORER to establish a standard scanning protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | 3 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time. |
|
| High dose | Experimental | 7 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| illuccix 68Ga-PSMA-11 Total Body PET-CT | Drug | Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparing the imaging quality using low dose and high dose Ga-68 PSMA-11 at various scan lengths. | In modulating the dose and scan time, including reconstitution of the images, we will identify optimal protocol for use of Illuccix on total body PET/CT through evaluation of image quality at variable dose and scan length. | 3 months |
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Inclusion Criteria:
Provision of signed and dated informed consent form
Male ≥ 18 years of age
Patients meeting clinical need for Illuccix PET scan:
Patient is physically able to lay flat for the PET-CT procedure
Exclusion Criteria:
1. Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dan Rogers | Contact | 616-330-3886 | clinical.research@bamfhealth.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BAMF Health | Recruiting | Grand Rapids | Michigan | 49503 | United States |
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