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

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:	March 2013
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	March 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:

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

Exclusion Criteria:

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.

Contacts and Locations

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
Baltimore, Maryland, United States, 21201

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:	January 14, 2013
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
Adenocarcinoma, Mucinous
Carcinoma
Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous

ClinicalTrials.gov processed this record on May 16, 2013

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