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NCT06353321 · ClinicalTrials.gov registry record

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

A clinical trial of Prostate Cancer, sponsored by University of Texas Southwestern Medical Center.

Recruiting
Registry status
25
Enrollment target
1
Study location

NCT06353321: Recruiting study of Prostate Cancer, sponsored by University of Texas Southwestern Medical Center.

NCT06353321 is a study of Prostate Cancer that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 25 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06353321, a study of Prostate Cancer, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.

RECRUITING
Registry status
25 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Qualitative imaging performance of the PET subsystem on the X1 system for detect PSMA-11 68Ga (Illuccix)-avid lesions (primary and metastatic) in patients with prostate cancer, relative to diagnostic \[68Ga\]-PSMA-11 PET-CT. This will be assessed by the enrolling investigator with the following question: Is there an Illuccix (PSMA-11 Ga68) avid target that correlates to the tumor location on the registered CT image? (Yes/No)

Conditions Studied

Interventions

  • DIAGNOSTIC_TEST PET-CT imaging subsystem of the RefleXion X1 System Device

Study Locations (1)

Texas

  • Ut Southwestern Medical Center - Dallas

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2024-12-12
Est. Completion 2026-12-14

What NCT06353321 shows while recruiting

NCT06353321 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (96% lower).

The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which PET-CT imaging subsystem of the RefleXion X1 System Device is the first listed.

NCT06353321 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT06353321 about?

NCT06353321 is a clinical study titled "Non-significant Risk (NSR) Study of [68Ga]-PSMA-11 (Illuccix) as a BgRT BioGuide on RefleXion X1". 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.

What is the current status of trial NCT06353321?

This trial is currently recruiting. The enrollment target is 25 participants. The study started on 2024-12-12. Estimated completion is 2026-12-14.

What conditions does trial NCT06353321 study?

This clinical trial studies the following conditions: Prostate Cancer.

What interventions are being tested in trial NCT06353321?

The interventions under investigation include: PET-CT imaging subsystem of the RefleXion X1 System Device (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT06353321?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06353321 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Prostate Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06353321's enrollment target sits among peer trials

25 626th of 735 higher than 103 of 735 other Prostate Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06353321, the US trial registry maintained by the National Library of Medicine. NCT06353321 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.