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Total Body PET-CT Imaging of Prostate Cancer Using Illuccix

Primary Purpose

Metastatic Castration-resistant Prostate Cancer

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
illuccix 68Ga-PSMA-11 Total Body PET-CT
Sponsored by
BAMF Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Metastatic Castration-resistant Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • BAMF HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low Dose

High dose

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 23, 2022
Last Updated
July 25, 2023
Sponsor
BAMF Health
Collaborators
Telix International Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05558956
Brief Title
Total Body PET-CT Imaging of Prostate Cancer Using Illuccix
Official Title
Total Body PET-CT Imaging of Prostate Cancer Using Illuccix (Kit for the Preparation of Ga-68 PSMA-11 Injection)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BAMF Health
Collaborators
Telix International Pty Ltd

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration-resistant Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Dose
Arm Type
Experimental
Arm Description
3 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time.
Arm Title
High dose
Arm Type
Experimental
Arm Description
7 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time.
Intervention Type
Drug
Intervention Name(s)
illuccix 68Ga-PSMA-11 Total Body PET-CT
Intervention Description
Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11
Primary Outcome Measure Information:
Title
Comparing the imaging quality using low dose and high dose Ga-68 PSMA-11 at various scan lengths.
Description
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.
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form Male ≥ 18 years of age Patients meeting clinical need for Illuccix PET scan: Patients with suspected metastasis who are candidates for initial definitive therapy Patients with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Rogers
Phone
616-330-3886
Email
clinical.research@bamfhealth.com
Facility Information:
Facility Name
BAMF Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Rogers
Phone
616-330-3886
Email
clinical.research@bamfhealth.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Total Body PET-CT Imaging of Prostate Cancer Using Illuccix

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