Total Body PET-CT Imaging of Prostate Cancer Using Illuccix

Metastatic Castration-resistant Prostate Cancer Clinical Trial

Official title:

Total Body PET-CT Imaging of Prostate Cancer Using Illuccix (Kit for the Preparation of Ga-68 PSMA-11 Injection)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05558956
• Other study ID #: BAMF-2022-03
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 1, 2022
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: BAMF Health
• Contact: Dan Rogers
• Phone: 616-330-3886
• Email: clinical.research[@]bamfhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• illuccix 68Ga-PSMA-11 Total Body PET-CT
Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11

Locations

Country	Name	City	State
United States	BAMF Health	Grand Rapids	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
BAMF Health	Telix International Pty Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing the imaging quality using low dose and high dose Ga-68 PSMA-11 at various scan lengths.	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.	3 months