Pancreatic Adenocarcinoma
Conditions
Keywords
4D-CT, Contrast Enhanced CT, Radiotherapy Simulation
Brief summary
The primary objective is to study the feasibility and efficacy of individually optimized CE 4D-CT for PDA in radiotherapy simulation.
Detailed description
Compared with current clinical practice, the individually optimized CE 4D-CT can potentially provide much improved tumor-to-parenchyma conspicuity of pancreatic adenocarcinoma. This will help the radiation oncologists or radiologists to contour the tumor with higher precision and confidence, and compute the tumor volume and tumor motion more accurately.
Interventions
OTHERContrast-enhanced 4D computed tomography
All enrolled patients each underwent three CT scans: a 4DCT immediately following a contrast-enhanced 3DCT and an individually optimized contrast-enhanced 4DCT.
Sponsors
University of Maryland, Baltimore
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients 18 years old or older 2. Patients with PDA who have not had surgical removal of their tumor and who are planned for treatment with radiotherapy in the Radiation Oncology Department at the University of Maryland. 3. Patients who have signed the contrast consent form and have been recommended by physicians to have contrast-enhanced CT scans. 4. Patients who have signed the consent form for this study
Exclusion criteria
1. Pregnant or breast-feeding women. 2. Patients with severely decreased renal function19-21. 3. Patients with known severe allergic reactions to contrast. 4. Patients who have difficulty lying flat on their back for extended periods of time. 5. Patients with breaths per minute (BPM) rate less than 10, due to the limitation of 4D-CT image reconstruction software.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | 1 year | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GI Group Study the feasibility and efficacy of individually optimized CE 4D-CT for PDA in radiotherapy simulation. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | GI Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation
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.
Time frame: 1 year
Population: Image data of 10 patients (of the 12 patients who completed the study) was good for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CE 3DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Anatomic details | 4.1 units on a scale | Standard Deviation 0.8 |
| CE 3DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Motion artifacts | 3.9 units on a scale | Standard Deviation 1 |
| CE 3DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Beam hardening | 4.2 units on a scale | Standard Deviation 0.8 |
| CE 3DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Enhancement of pancreatic tissue and tumor | 3.2 units on a scale | Standard Deviation 1 |
| 4DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Enhancement of pancreatic tissue and tumor | 1.7 units on a scale | Standard Deviation 0.9 |
| 4DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Anatomic details | 2.5 units on a scale | Standard Deviation 0.6 |
| 4DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Beam hardening | 3.3 units on a scale | Standard Deviation 0.9 |
| 4DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Motion artifacts | 3.4 units on a scale | Standard Deviation 0.9 |
| CE 4DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Enhancement of pancreatic tissue and tumor | 3.3 units on a scale | Standard Deviation 1 |
| CE 4DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Motion artifacts | 3.7 units on a scale | Standard Deviation 0.8 |
| CE 4DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Beam hardening | 3.5 units on a scale | Standard Deviation 0.8 |
| CE 4DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Anatomic details | 3.6 units on a scale | Standard Deviation 0.8 |
Primary
Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation
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.
Time frame: 1 year
Population: Image data of 10 patients (of the 12 patients who completed the study) was good for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CE 3DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Pancreas CT number (HU) | 49.2 HU | Standard Deviation 12.3 |
| CE 3DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Tumor CT number (HU) | 53.0 HU | Standard Deviation 9.2 |
| CE 3DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Tumor to pancreas contrast (HU) | 15.5 HU | Standard Deviation 20.7 |
| CE 3DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Noise (HU) | 12.5 HU | Standard Deviation 3.9 |
| 4DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Noise (HU) | 19.4 HU | Standard Deviation 5.8 |
| 4DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Pancreas CT number (HU) | 44.6 HU | Standard Deviation 15.9 |
| 4DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Tumor to pancreas contrast (HU) | 9.2 HU | Standard Deviation 9.2 |
| 4DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Tumor CT number (HU) | 58.9 HU | Standard Deviation 14.3 |
| CE 4DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Noise (HU) | 22.1 HU | Standard Deviation 5.7 |
| CE 4DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Tumor CT number (HU) | 76.3 HU | Standard Deviation 15 |
| CE 4DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Tumor to pancreas contrast (HU) | 16.7 HU | Standard Deviation 12.3 |
| CE 4DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | Pancreas CT number (HU) | 75.5 HU | Standard Deviation 21.2 |
Primary
Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation
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.
Time frame: 1 year
Population: Image data of 10 patients (of the 12 patients who completed the study) was good for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CE 3DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | 1.4 contrast to noise ratio | Standard Deviation 1.9 |
| 4DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | 0.6 contrast to noise ratio | Standard Deviation 0.7 |
| CE 4DCT | Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation | 0.8 contrast to noise ratio | Standard Deviation 0.6 |