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Completed

NCT Number: NCT01764659

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.

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Key information

Conditions

Pancreatic Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ummc Msgcc

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Contrast-enhanced 4D computed tomography

Other

All enrolled patients each underwent three CT scans: a 4DCT immediately following a contrast-enhanced 3DCT and an individually optimized contrast-enhanced 4DCT.

Primary outcomes

  1. Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation

    Time frame: 1 year

    Image quality (anatomic details, motion artifacts, beam hardening and enhancement of pancreatic tissue and tumor were scored from 1 to 5, with 1 being very poor and 5 being excellent), CT number of pancreas and tumor, tumor-to-pancreas contrast, image noise and contrast-to-noise ration (CNR) were compared among contrast-enhanced (CE) 4DCT, CE 3DCT and 4DCT without contrast enhancement.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

Individually Optimized Contrast-Enhancement 4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation

Acronym: GCC 1210

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 9, 2013
Registry last updated
Mar 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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