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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05558956
Other study ID # BAMF-2022-03
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date November 1, 2022
Est. completion date December 2023

Study information

Verified date March 2023
Source BAMF Health
Contact Dan Rogers
Phone 616-330-3886
Email clinical.research@bamfhealth.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Illuccix will be used per the prescribing instructions for PET-CT imaging on the United Imaging scanner uEXPLORER to establish a standard scanning protocol.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Male = 18 years of age 3. Patients meeting clinical need for Illuccix PET scan: 1. Patients with suspected metastasis who are candidates for initial definitive therapy 2. Patients with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level 4. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
illuccix 68Ga-PSMA-11 Total Body PET-CT
Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11

Locations

Country Name City State
United States BAMF Health Grand Rapids Michigan

Sponsors (2)

Lead Sponsor Collaborator
BAMF Health Telix International Pty Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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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