Total Body PET-CT Imaging of Prostate Cancer Using Illuccix

NCT ID: NCT05558956

Last Updated: 2023-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Metastatic Castration-resistant Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Low Dose

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11

High dose

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11

Interventions

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

Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Telix Pharmaceuticals (Innovations) Pty Limited

INDUSTRY

Sponsor Role collaborator

BAMF Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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BAMF Health

Grand Rapids, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dan Rogers

Role: CONTACT

616-330-3886

Facility Contacts

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Dan Rogers

Role: primary

616-330-3886

Other Identifiers

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BAMF-2022-03

Identifier Type: -

Identifier Source: org_study_id

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