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Trial Title:
Total Body PET-CT Imaging of Prostate Cancer Using Illuccix
NCT ID:
NCT05558956
Condition:
Metastatic Castration-resistant Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Gallium 68 PSMA-11
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
illuccix 68Ga-PSMA-11 Total Body PET-CT
Description:
Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11
Arm group label:
High dose
Arm group label:
Low Dose
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
BAMF Health
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dan Rogers
Phone:
616-330-3886
Email:
clinical.research@bamfhealth.com
Start date:
November 1, 2022
Completion date:
December 2023
Lead sponsor:
Agency:
BAMF Health
Agency class:
Other
Collaborator:
Agency:
Telix Pharmaceuticals (Innovations) Pty Limited
Agency class:
Industry
Source:
BAMF Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05558956
