NCT05558956

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Nov 2022

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 27, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

September 23, 2022

Last Update Submit

July 25, 2023

Conditions

Metastatic Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Low Dose

EXPERIMENTAL

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

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

High dose

EXPERIMENTAL

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

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

Interventions

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

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

High doseLow Dose

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \. Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BAMF Health

Grand Rapids, Michigan, 49503, United States

RECRUITING

Central Study Contacts

Dan Rogers

CONTACT

616-330-3886clinical.research@bamfhealth.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2022

First Posted

September 28, 2022

Study Start

November 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

July 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)