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Total Body PET-CT Imaging of Prostate Cancer Using Illuccix

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ClinicalTrials.gov Identifier: NCT05558956
Recruitment Status : Recruiting
First Posted : September 28, 2022
Last Update Posted : February 8, 2023
Sponsor:
Collaborator:
Telix International Pty Ltd
Information provided by (Responsible Party):
BAMF Health

Tracking Information
First Submitted Date  ICMJE September 23, 2022
First Posted Date  ICMJE September 28, 2022
Last Update Posted Date February 8, 2023
Actual Study Start Date  ICMJE November 1, 2022
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2022)
Comparing the imaging quality using low dose and high dose Ga-68 PSMA-11 at various scan lengths. [ Time Frame: 3 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Total Body PET-CT Imaging of Prostate Cancer Using Illuccix
Official Title  ICMJE Total Body PET-CT Imaging of Prostate Cancer Using Illuccix (Kit for the Preparation of Ga-68 PSMA-11 Injection)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Metastatic Castration-resistant Prostate Cancer
Intervention  ICMJE Drug: illuccix 68Ga-PSMA-11 Total Body PET-CT
Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11
Study Arms  ICMJE
  • Experimental: Low Dose
    3 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 8 min scan time.
    Intervention: Drug: illuccix 68Ga-PSMA-11 Total Body PET-CT
  • Experimental: High dose
    5 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 5 min scan time.
    Intervention: Drug: illuccix 68Ga-PSMA-11 Total Body PET-CT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 26, 2022)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dan Rogers 616-330-3886 clinical.research@bamfhealth.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05558956
Other Study ID Numbers  ICMJE BAMF-2022-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party BAMF Health
Original Responsible Party Same as current
Current Study Sponsor  ICMJE BAMF Health
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Telix International Pty Ltd
Investigators  ICMJE Not Provided
PRS Account BAMF Health
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP