Non-significant Risk (NSR) Study of [68Ga]-PSMA-11 (Illuccix) as a BgRT BioGuide on RefleXion X1

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06353321
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • PET-CT imaging subsystem of the RefleXion X1 System Device — DIAGNOSTIC_TEST
    Imaging performed only on the X1 platform immediately following already planned imaging using Illuccix for standard of care indications in men with prostate cancer of various stages, in order to assess performance of the X1 in comparison to diagnostic imaging scanners

Study Details

To qualitatively determine the imaging performance of PET-CT imaging subsystem of the RefleXion X1 System Device in patients undergoing standard-of-care (SOC) \[68Ga\]-PSMA-11 PET-CT using Illuccix on the same day.

Key Dates

Start date
Dec 12, 2024
Status verified
Jan 2026
Primary completion
Dec 12, 2026
Completion
Dec 14, 2026

Study Design

Enrollment
25 participants (estimated)

Arms

  • Arm: Single group non blinded
    Single Center Study, pilot/feasibility, private for profit observational study

Primary Outcome Measure

Qualitative assessment of RefleXion X1 imaging performance with Illuccix PSMA PET imaging agent immediately following a standard of care Illuccix PET/CT [ Time Frame: From time of Reflexion scan to 48 hours after scan for adverse event evaluation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ut Southwestern Medical CenterDallasTexas75390
SARAH NEUFELD
[email protected]
214-648-1836
LILIANA ROBLES
[email protected]
214 648 1836

Find similar trials in Dallas, TX

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Ut Southwestern Medical Center· Dallas, TX

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