Trial Outcomes & Findings for Dual-Energy CT on Plan Quality, Dose-delivery Accuracy, and Simulated Outcomes of Patients Treated With Proton or Photon Therapy (NCT NCT03403361)
NCT ID: NCT03403361
Last Updated: 2024-03-01
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Day 1
Results posted on
2024-03-01
Participant Flow
Participant milestones
| Measure |
Dual-Energy CT Scan
Patients enrolling in this study will undergo additional sequential DECT scan in addition to their routine SECT or DECT scan.
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Dual-Energy CT Scan
Patients enrolling in this study will undergo additional sequential DECT scan in addition to their routine SECT or DECT scan.
|
|---|---|
|
Overall Study
Not imaged due to issues during the pandemic
|
16
|
Baseline Characteristics
Dual-Energy CT on Plan Quality, Dose-delivery Accuracy, and Simulated Outcomes of Patients Treated With Proton or Photon Therapy
Baseline characteristics by cohort
| Measure |
Dual-Energy CT Scan
n=36 Participants
Patients enrolling in this study will undergo additional sequential DECT scan in addition to their routine SECT or DECT scan.
|
|---|---|
|
Age, Continuous
|
66.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: 16 participants did not have imaging due to staffing changes and lack of communication during the pandemic.
Outcome measures
| Measure |
Dual-Energy CT Scan
n=20 Participants
Patients enrolling in this study will undergo additional sequential DECT scan in addition to their routine SECT or DECT scan.
|
|---|---|
|
Dose Difference in 99% Planning Target Volume (PTV) Coverage Between Single Energy CT and Dual Energy CT
Head and Neck Patients
|
0.9 percentage relative to prescribed dose
Standard Deviation 1.8
|
|
Dose Difference in 99% Planning Target Volume (PTV) Coverage Between Single Energy CT and Dual Energy CT
Lung Patients
|
1.0 percentage relative to prescribed dose
Standard Deviation 2.8
|
Adverse Events
Dual-Energy CT Scan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Clifford Robinson
Washington University School of Medicine
Phone: 314-362-8567
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place