Total Body PET-CT Imaging of Prostate Cancer Using Illuccix

Clinicaltrials.gov ID: NCT05558956
db-list-check Status RECRUITING
b-loader Phase EARLY_PHASE1
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 100

Conditions

Metastatic Castration-resistant Prostate Cancer

Drugs

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

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

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-CT

    Description:

    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-CT

    Description:

    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.

Time Frame: 3 months

Timeline

  • Last Updated
    July 27, 2023
  • Start Date
    September 28, 2022
  • Today
    January 16, 2025
  • Completion Date ( Estimated )
    December 1, 2023

Similar Trials

light-list-check RECRUITING light-blue-people 21 - 64 Years
light-list-check RECRUITING light-blue-people ≥ 18 Years
light-list-check RECRUITING light-blue-people ≥ 65 Years