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

This study is not yet open for participant recruitment.
Verified January 2013 by University of Maryland
Sponsor:
Information provided by (Responsible Party):
Department of Radiation Oncology, University of Maryland
ClinicalTrials.gov Identifier:
NCT01764659
First received: January 2, 2013
Last updated: January 14, 2013
Last verified: January 2013
History of Changes

January 2, 2013
January 14, 2013
March 2013
March 2014   (final data collection date for primary outcome measure)
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;
Primary Objective Anaylsis [ 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;
Complete list of historical versions of study NCT01764659 on ClinicalTrials.gov Archive Site
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4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation
Individually Optimized Contrast-Enhancement 4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

GI/GU multi-d clinic
Pancreatic Adenocarcinoma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
10
December 2014
March 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Bahiyyah Jackson, BS, MS 410-328-7586 bjackson1@umm.edu
Contact: Suzanne Grim, BS, MS 410-328-7501 sgrim@umm.edu
United States
 
NCT01764659
HP-00052534
Yes
Department of Radiation Oncology, University of Maryland
University of Maryland
Not Provided
Principal Investigator: Wei Lu, Ph. D., DABR UMMC MSGCC
University of Maryland
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP