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The primary objective is to study the feasibility and efficacy of individually optimized CE 4D-CT for PDA in radiotherapy simulation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All enrolled patients | Contrast-enhanced 4D computed tomography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast-enhanced 4D computed tomography | Other | All enrolled patients each underwent three CT scans: a 4DCT immediately following a contrast-enhanced 3DCT and an individually optimized contrast-enhanced 4DCT. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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GI/GU multi-d clinic
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| Name | Affiliation | Role |
|---|---|---|
| Wei Lu, Ph. D., DABR | UMMC MSGCC | Principal Investigator |
| Hao H Zhang, Ph. D. | UMMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ummc Msgcc | Baltimore | Maryland | 21201 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Patients | Individually optimized CE 4D-CT |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | GI Group | Study the feasibility and efficacy of individually optimized CE 4D-CT for PDA in radiotherapy simulation. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Image data of 10 patients (of the 12 patients who completed the study) was good for analysis. | Posted | Mean | Standard Deviation | units on a scale | 1 year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Enrolled Patients | One death among enrolled patients, which was not directly related to this research. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Howard Zhang, PhD | UMMC MSGCC | (410)706-6510 | hzhang@umm.edu |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
4DCT without contrast
| OG002 | CE 4DCT | Individually optimized contrast-enhanced 4DCT |
|
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| 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. | Image data of 10 patients (of the 12 patients who completed the study) was good for analysis. | Posted | Mean | Standard Deviation | HU | 1 year |
|
|
|
| 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. | Image data of 10 patients (of the 12 patients who completed the study) was good for analysis. | Posted | Mean | Standard Deviation | contrast to noise ratio | 1 year |
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|
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| 1 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
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| Tumor to pancreas contrast (HU) |
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| Noise (HU) |
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