Trial Outcomes & Findings for 4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation (NCT NCT01764659)

Last Updated: 2020-03-27

Results Overview

Image quality (anatomic details, motion artifacts, beam hardening and enhancement of pancreatic tissue and tumor were scored from 1 to 5, with 1 being very poor and 5 being excellent), CT number of pancreas and tumor, tumor-to-pancreas contrast, image noise and contrast-to-noise ration (CNR) were compared among contrast-enhanced (CE) 4DCT, CE 3DCT and 4DCT without contrast enhancement.

Recruitment status

COMPLETED

Target enrollment

14 participants

Primary outcome timeframe

1 year

Results posted on

2020-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	All Enrolled Patients Individually optimized CE 4D-CT
Overall Study STARTED	14
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	All Enrolled Patients Individually optimized CE 4D-CT
Overall Study Death	1
Overall Study Physician Decision	1

Baseline Characteristics

4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GI Group n=14 Participants Study the feasibility and efficacy of individually optimized CE 4D-CT for PDA in radiotherapy simulation.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	9 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

PRIMARY outcome

Timeframe: 1 year

Population: Image data of 10 patients (of the 12 patients who completed the study) was good for analysis.

Outcome measures

Outcome measures
Measure	CE 3DCT n=10 Participants Contrast-enhanced 3DCT	4DCT n=10 Participants 4DCT without contrast	CE 4DCT n=10 Participants Individually optimized contrast-enhanced 4DCT
Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation Anatomic details	4.1 units on a scale Standard Deviation 0.8	2.5 units on a scale Standard Deviation 0.6	3.6 units on a scale Standard Deviation 0.8
Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation Motion artifacts	3.9 units on a scale Standard Deviation 1.0	3.4 units on a scale Standard Deviation 0.9	3.7 units on a scale Standard Deviation 0.8
Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation Beam hardening	4.2 units on a scale Standard Deviation 0.8	3.3 units on a scale Standard Deviation 0.9	3.5 units on a scale Standard Deviation 0.8
Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation Enhancement of pancreatic tissue and tumor	3.2 units on a scale Standard Deviation 1.0	1.7 units on a scale Standard Deviation 0.9	3.3 units on a scale Standard Deviation 1.0

PRIMARY outcome

Timeframe: 1 year

Population: Image data of 10 patients (of the 12 patients who completed the study) was good for analysis.

Outcome measures

Outcome measures
Measure	CE 3DCT n=10 Participants Contrast-enhanced 3DCT	4DCT n=10 Participants 4DCT without contrast	CE 4DCT n=10 Participants Individually optimized contrast-enhanced 4DCT
Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation Pancreas CT number (HU)	49.2 HU Standard Deviation 12.3	44.6 HU Standard Deviation 15.9	75.5 HU Standard Deviation 21.2
Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation Tumor CT number (HU)	53.0 HU Standard Deviation 9.2	58.9 HU Standard Deviation 14.3	76.3 HU Standard Deviation 15.0
Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation Tumor to pancreas contrast (HU)	15.5 HU Standard Deviation 20.7	9.2 HU Standard Deviation 9.2	16.7 HU Standard Deviation 12.3
Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation Noise (HU)	12.5 HU Standard Deviation 3.9	19.4 HU Standard Deviation 5.8	22.1 HU Standard Deviation 5.7

PRIMARY outcome

Timeframe: 1 year

Population: Image data of 10 patients (of the 12 patients who completed the study) was good for analysis.

Outcome measures

Outcome measures
Measure	CE 3DCT n=10 Participants Contrast-enhanced 3DCT	4DCT n=10 Participants 4DCT without contrast	CE 4DCT n=10 Participants Individually optimized contrast-enhanced 4DCT
Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation	1.4 contrast to noise ratio Standard Deviation 1.9	0.6 contrast to noise ratio Standard Deviation 0.7	0.8 contrast to noise ratio Standard Deviation 0.6

Adverse Events

All Enrolled Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Howard Zhang, PhD

UMMC MSGCC

Phone: (410)706-6510

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place