[18F]-rhPSMA PET-CT Imaging Performance in Patients With Prostate Cancer
NCT ID: NCT06580015
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-03-25
2027-01-09
Brief Summary
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Detailed Description
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I. To evaluate the imaging performance of flotufolastat F-18 gallium (\[18F\]-rhPSMA) PET-CT imaging subsystem of the RefleXion Medical Radiotherapy System Device in patients with lesions detected on standard-of-care (SOC) \[18F\]-rhPSMA PET-CT on the same day.
SECONDARY OBJECTIVES:
I. To evaluate the frequency that SOC Posluma imaging will result in the ability to distinctly identify and separate PET activity from bladder activity to aid in the detection, lesion contouring, RT planning and RT delivery for intra-prostatic lesions, prostate bed lesions (salvage RT) or lesions near the bladder.
II. To evaluate the frequency that SOC Posluma imaging will result in a change in radiotherapy planning through either exclusion due to extra-pelvic metastatic disease or detection of disease that results in a modification of RT field coverage or dose.
III. Evaluate the potential for using the X1 RMRS PET used to generate an acceptable BgRT plan such that dosimetric parameters for the target and the nearby normal anatomy are met based on investigator assessment.
OUTLINE:
Patients receive SOC flotufolastat F-18 gallium intravenously (IV) and undergo PET-CT on study. Patients then undergo X1 RMRS PET-CT imaging-only session 120 minutes post-injection.
After completion of study intervention, patients are followed up within 72 hours of PET imaging-only session.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Device Feasibility ([18F]-rhPSMA PET-CT, X1 RMRS PET-CT)
Patients receive SOC flotufolastat F-18 gallium IV and undergo PET-CT on study. Patients then undergo X1 RMRS PET-CT imaging-only session 120 minutes post-injection.
Computed Tomography
Undergo PET-CT
Flotufolastat F-18 Gallium
Given IV
Medical Device Usage and Evaluation
Undergo X1 RMRS PET-CT
Positron Emission Tomography
Undergo PET-CT
Interventions
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Computed Tomography
Undergo PET-CT
Flotufolastat F-18 Gallium
Given IV
Medical Device Usage and Evaluation
Undergo X1 RMRS PET-CT
Positron Emission Tomography
Undergo PET-CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age: ≥ 21 years
* Patients with SOC \[18F\]-RhPSMA PET-CT in whom a PET avid lesion is identified
* Able to get same day X1 RMRS PET
Exclusion Criteria
* Patient weight exceeding the weight limit (450 pounds) outlined per X1 RMRS specifications sheet
21 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Y Wong, MD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2024-06849
Identifier Type: REGISTRY
Identifier Source: secondary_id
24163
Identifier Type: OTHER
Identifier Source: secondary_id
24163
Identifier Type: -
Identifier Source: org_study_id
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