Prostate CancerNCT06353321
Non-significant Risk (NSR) Study of [68Ga]-PSMA-11 (Illuccix) as a BgRT BioGuide on RefleXion X1
An observational study of Prostate Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PET-CT imaging subsystem of the RefleXion X1 System Device
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2024to 14 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patient population selected for this investigation is meant to optimally represent the spectrum of cases, with respect to motion and radiographic environment that a radiation oncologist may encounter in practice.
Who may be able to join
- Men with prostate adenocarcinoma undergoing standard of care PSMA-PET imaging for initial staging or re-staging at suspected relapse/progression
Who cannot join
- 1. Known psychiatric or substance abuse disorder which in the opinion of the investigator would interfere with study conduct
- 2. Patient weight exceeding 450 lb (weight limit of RefleXion X1 system)
- 3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ut Southwestern Medical Center
Dallas, Texas, 75390
SARAH NEUFELD, 214-648-1836, SARAH.HARDEE@UTSOUTHWESTERN.EDU
LILIANA ROBLES, 214 648 1836, LILIANA.ROBLES@UTSOUTHWESTERN.EDU
About this study
Official title: 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
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.
Read the detailed description
In this non-significant risk (NSR) study, investigators will perform imaging only (no treatment) on the X1 platform immediately following an already planned PET/CT diagnostic imaging using Illuccix for standard of care indications in men with prostate cancer of various stages. This approach will be used to assess imaging performance of the X1 in comparison to diagnostic imaging scanners. Evidence from this study will supplement and enhance technical understanding of the PSMA-11-guided BgRT delivery in the setting of prostate cancer. As such, the patient population selected for this investigation is meant to optimally represent the spectrum of cases, with respect to motion and radiographic environment that a radiation oncologist may encounter in practice.
- Conditions
- Prostate Cancer
- Being tested
- PET-CT imaging subsystem of the RefleXion X1 System Device
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CT imaging subsystem of the RefleXion X1 System DeviceDiagnostic 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 group | Role | What they receive |
|---|---|---|
| Single group non blinded | Single Center Study, pilot/feasibility, private for profit observational study Receives: Diagnostic Test: PET-CT imaging subsystem of the RefleXion X1 System Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative assessment of RefleXion X1 imaging performance with Illuccix PSMA PET imaging agent immediately following a standard of care Illuccix PET/CT
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)
Measured: From time of Reflexion scan to 48 hours after scan for adverse event evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start12 Dec 2024
- Primary completion12 Dec 2026 (estimated)
- Study completion14 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- RefleXion Medical
- Responsible party
- Principal investigator, Neil Desai, University of Texas Southwestern Medical Center
- Investigators
- Neil Desai, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353321
- Sponsor's protocol ID
- STU-2024-0024
- Status last verified
- Jan 2026
- First submitted
- 26 Mar 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06353321
- Acronym / sponsor ID
- STU-2024-0024
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- RefleXion Medical
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 14 Dec 2026 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this non-significant risk (NSR) study, investigators will perform imaging only (no treatment) on the X1 platform immediately following an already planned PET/CT diagnostic imaging using Illuccix for standard of care indications in men with prostate cancer of various stages. This approach will be used to assess imaging performance of the X1 in comparison to diagnostic imaging scanners. Evidence from this study will supplement and enhance technical understanding of the PSMA-11-guided BgRT delivery in the setting of prostate cancer. As such, the patient population selected for this investigation is meant to optimally represent the spectrum of cases, with respect to motion and radiographic environment that a radiation oncologist may encounter in practice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group non blinded | – | Diagnostic Test: PET-CT imaging subsystem of the RefleXion X1 System DeviceSingle Center Study, pilot/feasibility, private for profit observational study |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patient population selected for this investigation is meant to optimally represent the spectrum of cases, with respect to motion and radiographic environment that a radiation oncologist may encounter in practice.
Key inclusion criteria (1 listed)
- Men with prostate adenocarcinoma undergoing standard of care PSMA-PET imaging for initial staging or re-staging at suspected relapse/progression
Key exclusion criteria (3 listed)
- 1. Known psychiatric or substance abuse disorder which in the opinion of the investigator would interfere with study conduct
- 2. Patient weight exceeding 450 lb (weight limit of RefleXion X1 system)
- 3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-CT imaging subsystem of the RefleXion X1 System DeviceImaging 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 | Diagnostic test | Single group non blinded |
Primary outcome
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neil Desai, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Neufeld, MS, MBA (214 648-1836, Sarah.Hardee@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.