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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-05684 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 22189 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic ([18F]-DCFPyL PET-CT, X1 RMRS PET-CT) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo PET/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Tumor Visualized on X1 RefleXion Medical Radiotherapy System (RMRS) Positron Emission Tomography-computed Tomography (PET-CT) | To determine imaging performance of the X1 PET scan, the number of tumors clearly visualized on PET scan were reported. | Up to 72 hours after completion of scan |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Cases Where X1 RMRS [18F]-DCFPyL PET Data Can be Used to Generate an Acceptable Biology-guided Radiotherapy (BgRT) Plan | The true positive lesions identified on the X1 PET images will be identified and used for BgRT planning. Simulated planning using the RefleXion treatment planning software will be performed, and the radiation dose to organs at risk calculated. Principal investigator will determine whether this plan is acceptable or not. The percent of cases in which RefleXion [18F]-DCFPyL PET data led to an acceptable plan will be recorded (descriptive statistics). Descriptive statistics will be utilized to quantify results. Mean, standard deviation, IQR, and range will be reported for each continuous variable. Frequency and percentage will be reported for categorical variables. Statistical significance will be assessed at the 0.05 level, one-sided. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Y Wong | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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A total of 34 patients provided informed consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Computed Tomography: Undergo PET/CT Fluorine F 18 Piflufolastat: Given IV Positron Emission Tomography: Undergo PET/CT |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Computed Tomography: Undergo PET/CT Fluorine F 18 Piflufolastat: Given IV Positron Emission Tomography: Undergo PET/CT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Tumor Visualized on X1 RefleXion Medical Radiotherapy System (RMRS) Positron Emission Tomography-computed Tomography (PET-CT) | To determine imaging performance of the X1 PET scan, the number of tumors clearly visualized on PET scan were reported. | Biology-guided radiotherapy plans were successfully generated for 18 patients. | Posted | Count of Participants | Participants | Up to 72 hours after completion of scan |
|
Adverse events were collected from the beginning of the imaging-only session on the X1 RMRS system and continued until 72 hours after the end of the scan.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Computed Tomography: Undergo PET/CT Fluorine F 18 Piflufolastat: Given IV Positron Emission Tomography: Undergo PET/CT |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Frankel, Ph.D. | City of Hope | 6262185265 | pfrankel@coh.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 8, 2022 | Nov 17, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 28, 2022 | Nov 17, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C572626 | 2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid |
| D049268 | Positron-Emission Tomography |
| ID | Term |
|---|---|
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| Fluorine F 18 Piflufolastat | Other | Given IV |
|
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| Positron Emission Tomography | Device | Undergo PET/CT |
|
|
| Up to 72 hours |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Percent of Cases Where X1 RMRS [18F]-DCFPyL PET Data Can be Used to Generate an Acceptable Biology-guided Radiotherapy (BgRT) Plan | The true positive lesions identified on the X1 PET images will be identified and used for BgRT planning. Simulated planning using the RefleXion treatment planning software will be performed, and the radiation dose to organs at risk calculated. Principal investigator will determine whether this plan is acceptable or not. The percent of cases in which RefleXion [18F]-DCFPyL PET data led to an acceptable plan will be recorded (descriptive statistics). Descriptive statistics will be utilized to quantify results. Mean, standard deviation, IQR, and range will be reported for each continuous variable. Frequency and percentage will be reported for categorical variables. Statistical significance will be assessed at the 0.05 level, one-sided. | Posted | Count of Participants | Participants | Up to 72 hours |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 4 |
| 20 |
| Fatigue | General disorders | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | Non-systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |