4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation (GCC 1210)
Verified April 2014 by University of Maryland
Information provided by (Responsible Party):
Department of Radiation Oncology, University of Maryland
First received: January 2, 2013
Last updated: April 22, 2014
Last verified: April 2014
The primary objective is to study the feasibility and efficacy of individually optimized CE 4D-CT for PDA in radiotherapy simulation.
||Observational Model: Case-Only
Time Perspective: Prospective
||Individually Optimized Contrast-Enhancement 4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation
Primary Outcome Measures:
- Primary Objective Analysis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
First, experienced radiologists or radiation oncologists specialized in gastrointestinal (GI)/pancreas disease will score the CT images by a qualitative evaluation of:
(1) General image quality, in terms of anatomical details, motion artifacts and beam hardening;
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients 18 years old or older
- 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.
- Patients who have signed the contrast consent form and have been recommended by physicians to have contrast-enhanced CT scans.
- Patients who have signed the consent form for this study
- Pregnant or breast-feeding women.
- Patients with severely decreased renal function19-21.
- Patients with known severe allergic reactions to contrast.
- Patients who have difficulty lying flat on their back for extended periods of time.
- Patients with breaths per minute (BPM) rate less than 10, due to the limitation of 4D-CT image reconstruction software.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764659
|Baltimore, Maryland, United States, 21201 |
|Contact: Bahiyyah Jackson, MS 410-328-7586 firstname.lastname@example.org |
|Contact: Suzanne Grim, MS 410-328-7501 email@example.com |
|Principal Investigator: Wei Lu, PhD |
University of Maryland
||Wei Lu, Ph. D., DABR
No publications provided
||Department of Radiation Oncology, Assistant Professor, Physics, University of Maryland
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 2, 2013
||April 22, 2014
||United States: Institutional Review Board
Keywords provided by University of Maryland:
Contrast Enhanced CT
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type