Trial Outcomes & Findings for RefleXion PET/CT Imaging Performance in Patients With Prostate Cancer (NCT NCT05470699)

NCT ID: NCT05470699

Last Updated: 2025-12-17

Results Overview

To determine imaging performance of the X1 PET scan, the number of tumors clearly visualized on PET scan were reported.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

34 participants

Primary outcome timeframe

Up to 72 hours after completion of scan

Results posted on

2025-12-17

Participant Flow

A total of 34 patients provided informed consent.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	34
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Did not receive intervention	13
Overall Study Ineligible	1

Baseline Characteristics

RefleXion PET/CT Imaging Performance in Patients With Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic ([18F]-DCFPyL PET-CT, X1 RMRS PET-CT) n=20 Participants 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
Age, Continuous	72 years n=6 Participants
Sex: Female, Male Female	0 Participants n=6 Participants
Sex: Female, Male Male	20 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants
Race (NIH/OMB) Asian	5 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	2 Participants n=6 Participants
Race (NIH/OMB) White	11 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=6 Participants
Region of Enrollment United States	20 participants n=6 Participants

PRIMARY outcome

Timeframe: Up to 72 hours after completion of scan

Population: Biology-guided radiotherapy plans were successfully generated for 18 patients.

To determine imaging performance of the X1 PET scan, the number of tumors clearly visualized on PET scan were reported.

Outcome measures

Outcome measures
Measure	Diagnostic ([18F]-DCFPyL PET-CT, X1 RMRS PET-CT) n=18 Participants 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
Number of Participants With Tumor Visualized on X1 RefleXion Medical Radiotherapy System (RMRS) Positron Emission Tomography-computed Tomography (PET-CT)	1 Participants

SECONDARY outcome

Timeframe: Up to 72 hours

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.

Outcome measures

Outcome measures
Measure	Diagnostic ([18F]-DCFPyL PET-CT, X1 RMRS PET-CT) n=20 Participants 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
Percent of Cases Where X1 RMRS [18F]-DCFPyL PET Data Can be Used to Generate an Acceptable Biology-guided Radiotherapy (BgRT) Plan	18 Participants

Adverse Events

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

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Diagnostic ([18F]-DCFPyL PET-CT, X1 RMRS PET-CT) n=20 participants at risk 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
General disorders Fatigue	5.0% 1/20 • Number of events 1 • 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.
Nervous system disorders Peripheral sensory neuropathy	5.0% 1/20 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	5.0% 1/20 • Number of events 1 • 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.
Gastrointestinal disorders Diarrhea	5.0% 1/20 • Number of events 1 • 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.

Additional Information

Paul Frankel, Ph.D.

City of Hope

Phone: 6262185265

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place