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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 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: April 22, 2014
Last verified: April 2014
  Purpose

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


Condition
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;



Estimated Enrollment: 10
Study Start Date: July 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

GI/GU multi-d clinic

Criteria

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
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

Contacts
Contact: Bahiyyah Jackson, BS, MS 410-328-7586 bjackson1@umm.edu
Contact: Suzanne Grim, BS, MS 410-328-7501 sgrim@umm.edu

Locations
United States, Maryland
Ummc Msgcc Recruiting
Baltimore, Maryland, United States, 21201
Contact: Bahiyyah Jackson, MS    410-328-7586    bjackson1@umm.edu   
Contact: Suzanne Grim, MS    410-328-7501    sgrim@umm.edu   
Principal Investigator: Wei Lu, PhD         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Wei Lu, Ph. D., DABR UMMC MSGCC
  More Information

No publications provided

Responsible Party: Department of Radiation Oncology, Assistant Professor, Physics, University of Maryland
ClinicalTrials.gov Identifier: NCT01764659     History of Changes
Other Study ID Numbers: HP-00052534
Study First Received: January 2, 2013
Last Updated: April 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
4D-CT
Contrast Enhanced CT
Radiotherapy Simulation

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

ClinicalTrials.gov processed this record on October 29, 2014