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NCT06353321Not yet recruiting

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

Non-significant Risk (NSR) Study of [68Ga]-PSMA-11 (Illuccix) as a BgRT BioGuide on the RefleXion X1 System in Patients Already Undergoing Diagnostic PET (Positron Emission Tomography) PSMA (Prostate Specific Membrane Antigen) Imaging
University of Texas Southwestern Medical CenterClinicalTrials.govdiagnostic test
Study focus
Disease/Condition
Prostate Cancer
Drug/Device/Intervention
PET-CT imaging subsystem of the RefleXion X1 System Device
Study type
Observational
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
University of Texas Southwestern Medical Center
Timeline & enrollment
Phase
N/A
Start date
Sep 01, 2024
End date
Dec 01, 2025
Enrollment
25 participants
Primary outcome

Qualitative assessment of RefleXion X1 imaging performance with Illuccix PSMA PET imaging agent immediately following a standard of care Illuccix PET/CT

Summary

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.

ICD-10 classifications
Malignant neoplasm of prostateHyperplasia of prostateDisorder of prostate, unspecifiedOther disorders of prostateCarcinoma in situ: Prostate
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06353321
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06353321 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Texas Southwestern Medical Center and is currently Not yet recruiting. The study focuses on Prostate Cancer. Target enrollment is 25 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.