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Total Body PET-CT Imaging of Prostate Cancer Using Illuccix

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05558956
Recruitment Status : Not yet recruiting
First Posted : September 28, 2022
Last Update Posted : September 28, 2022
Sponsor:
Collaborator:
Telix International Pty Ltd
Information provided by (Responsible Party):
BAMF Health

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.

Condition or disease Intervention/treatment Phase
Metastatic Castration-resistant Prostate Cancer Drug: illuccix 68Ga-PSMA-11 Total Body PET-CT Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Total Body PET-CT Imaging of Prostate Cancer Using Illuccix (Kit for the Preparation of Ga-68 PSMA-11 Injection)
Estimated Study Start Date : October 2022
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Dose
5 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 8 min scan time.
Drug: illuccix 68Ga-PSMA-11 Total Body PET-CT
Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11

Experimental: High dose
5 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 5 min scan time.
Drug: illuccix 68Ga-PSMA-11 Total Body PET-CT
Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05558956


Contacts
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Contact: Dan Rogers 616-330-3886 clinical.research@bamfhealth.com

Locations
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United States, Michigan
BAMF Health
Grand Rapids, Michigan, United States, 49503
Contact: Dan Rogers    616-330-3886    clinical.research@bamfhealth.com   
Sponsors and Collaborators
BAMF Health
Telix International Pty Ltd
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Responsible Party: BAMF Health
ClinicalTrials.gov Identifier: NCT05558956    
Other Study ID Numbers: BAMF-2022-03
First Posted: September 28, 2022    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Gallium 68 PSMA-11
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action