Recruiting
Early Phase 1

Illuccix

Sponsor:

BAMF Health

Code:

NCT05558956

Conditions

Metastatic Castration-resistant Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

illuccix 68Ga-PSMA-11 Total Body PET-CT

Study Details

Brief 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.

Conditions

Metastatic Castration-resistant Prostate Cancer

Study ID

NCT05558956

Start date

Nov 1, 2022

Status verified date

Mar, 2023

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Low Dose

3 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time.

experimental: High dose

7 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time.

Interventions

illuccix 68Ga-PSMA-11 Total Body PET-CT

Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11

Primary outcome measure

  • Comparing the imaging quality using low dose and high dose Ga-68 PSMA-11 at various scan lengths. [ Time Frame: 3 months ]

Central Contacts and Locations

Locations

BAMF Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

More Information

Sponsor

BAMF Health

Last update posted

Jul 27, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BAMF Health on 2023-07-27.