4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation (GCC 1210)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01764659
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : March 17, 2015
Information provided by (Responsible Party):
Department of Radiation Oncology, University of Maryland

Brief Summary:
The primary objective is to study the feasibility and efficacy of individually optimized CE 4D-CT for PDA in radiotherapy simulation.

Condition or disease
Pancreatic Adenocarcinoma

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.

Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Individually Optimized Contrast-Enhancement 4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation
Study Start Date : July 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Primary Outcome Measures :
  1. Primary Objective Analysis [ Time Frame: 1 year ]

    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;

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
GI/GU multi-d clinic

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01764659

United States, Maryland
Ummc Msgcc
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Principal Investigator: Wei Lu, Ph. D., DABR UMMC MSGCC

Responsible Party: Department of Radiation Oncology, Assistant Professor, Physics, University of Maryland Identifier: NCT01764659     History of Changes
Other Study ID Numbers: HP-00052534
First Posted: January 9, 2013    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by Department of Radiation Oncology, University of Maryland:
Contrast Enhanced CT
Radiotherapy Simulation

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type