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

This study has been completed.
Information provided by (Responsible Party):
Department of Radiation Oncology, University of Maryland Identifier:
First received: January 2, 2013
Last updated: March 16, 2015
Last verified: March 2015
The primary objective is to study the feasibility and efficacy of individually optimized CE 4D-CT for PDA in radiotherapy simulation.

Pancreatic Adenocarcinoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Individually Optimized Contrast-Enhancement 4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation

Further study details as provided by University of Maryland:

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;

Enrollment: 14
Study Start Date: July 2013
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Department of Radiation Oncology, Assistant Professor, Physics, University of Maryland Identifier: NCT01764659     History of Changes
Other Study ID Numbers: HP-00052534 
Study First Received: January 2, 2013
Last Updated: March 16, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Contrast Enhanced CT
Radiotherapy Simulation

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms processed this record on October 26, 2016