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

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

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

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 1

Population: 16 participants did not have imaging due to staffing changes and lack of communication during the pandemic.

Outcome measures

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

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place