Total Body PET-CT Imaging of Prostate Cancer Using Illuccix
Conditions
Metastatic Castration-resistant Prostate CancerDrugs
illuccix 68Ga-PSMA-11 Total Body PET-CTSummary
Illuccix will be used per the prescribing instructions for PET-CT imaging on the United Imaging scanner uEXPLORER to establish a standard scanning protocol.
Locations
1 location Found with status Recruiting
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.
Study Plan
Low Dose
EXPERIMENTAL
3 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time.
DRUG:
illuccix 68Ga-PSMA-11 Total Body PET-CTDescription:
Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11
High dose
EXPERIMENTAL
7 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time.
DRUG:
illuccix 68Ga-PSMA-11 Total Body PET-CTDescription:
Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11
Outcome Measures
Primary Outcome Measures
Comparing the imaging quality using low dose and high dose Ga-68 PSMA-11 at various scan lengths.
Timeline
Last Updated
July 27, 2023Start Date
September 28, 2022Today
February 5, 2025Completion Date ( Estimated )
December 1, 2023
Sponsors of this trial
Lead Sponsor
BAMF HealthCollaborating Sponsors
Telix Pharmaceuticals (Innovations) Pty Limited