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RefleXion PET/CT Imaging Performance in Patients With Prostate Cancer

NCT ID: NCT05470699

Last Updated: 2025-12-17

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-29

Study Completion Date

2026-04-13

Brief Summary

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This clinical trial examines RefleXion Medical Radiotherapy System (RMRS) imaging to the standard of care (SOC) \[18F\]-DCFPyL positron emission tomography-computed tomography (PET-CT) imaging in patients with prostate cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of a tracer, \[18F\]-DCFPyL, that binds to prostate specific membrane antigen (PSMA) on tumor cells. These PSMA tumor cells can then be identified on PET imaging. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. The RMRS is a imaging-therapy combination system that can plan for and deliver radiation therapy as well perform \[18F\]-DCFPyL PET-CT imaging. Comparing the imaging from the standard of care \[18F\]-DCFPyL-PET-CT with the \[18F\]-DCFPyL imaging from RMRS may help improve the quality of the imaging captured and determine if imaging can be done on the RMRS at the same time as planning for radiation therapy, which would reduce the number of scans needed to plan for radiation for prostate cancer.

Detailed Description

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PRIMARY OBJECTIVE:

I. To assess imaging performance of the fluorine F 18 piflufolastat (\[18F\]-DCFPyL) PET-CT subsystem on the X1 RMRS to detect lesions (primary and metastatic) in patients with prostate cancer.

SECONDARY OBJECTIVE:

I. To determine the feasibility of generating a biology-guided radiotherapy (BgRT) plan using X1 RMRS-acquired \[18F\]-DCFPyL PET data derived from the imaging-only session at the studied dose level.

OUTLINE:

Patients receive \[18F\]-DCFPyL intravenously (IV) and undergo \[18F\]-DCFPyL PET-CT over 30 minutes per standard of care (SOC). Patients with PET avid lesions then undergo a X1 RMRS PET-CT imaging-only session within 120 minutes of injection over 20-35 minutes.

After completion of study, patients are followed up within 72 hours.

Conditions

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Prostate Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic ([18F]-DCFPyL PET-CT, X1 RMRS PET-CT)

Patients receive \[18F\]-DCFPyL IV and undergo \[18F\]-DCFPyL PET-CT over 30 minutes per SOC. Patients with PET avid lesions then undergo a X1 RMRS PET-CT imaging-only session within 120 minutes of injection over 20-35 minutes.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Fluorine F 18 Piflufolastat

Intervention Type OTHER

Given IV

Positron Emission Tomography

Intervention Type DEVICE

Undergo PET/CT

Interventions

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Computed Tomography

Undergo PET/CT

Intervention Type PROCEDURE

Fluorine F 18 Piflufolastat

Given IV

Intervention Type OTHER

Positron Emission Tomography

Undergo PET/CT

Intervention Type DEVICE

Other Intervention Names

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CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized Tomography CT CT Scan tomography 18F-DCFPyL Fluorine F 18 DCFPyL Piflufolastat F 18 Piflufolastat F-18 Piflufolastat F18 Pylarify Medical Imaging, Positron Emission Tomography PET PET Scan Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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Inclusion Criteria

* Documented informed consent of the participant and/or legally authorized representative
* Age \>= 21 years
* Patients undergoing SOC \[18F\]-DCFPyL PET-CT
* Patients should be scheduled for \[18F\]-DCFPyL PET-CT prior to study entry

Exclusion Criteria

* Known psychiatric or substance abuse disorder that would interfere with conduct of the study
* Patient weight exceeding the weight limit (450 pounds) outlined per X1 RMRS specifications sheet
Minimum Eligible Age

21 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Y Wong

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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NCI-2022-05684

Identifier Type: REGISTRY

Identifier Source: secondary_id

22189

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22189

Identifier Type: -

Identifier Source: org_study_id