4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation

Completed

• Conditions: Pancreatic Adenocarcinoma
• Interventions: Other: Contrast-enhanced 4D computed tomography

• Registration Number: NCT01764659
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-01-02
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-09
• Study Start: 2013-07
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2017-08-22
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-16
• Last Update Submitted: 2020-03-16
• Results First Posted: 2020-03-27
• Last Update Posted: 2020-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All enrolled patients	Contrast-enhanced 4D computed tomography	Contrast-enhanced 4D computed tomography

Primary Outcome Measures

Name	Time	Method
Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation	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.

Trial Locations

Locations (1)

Ummc Msgcc; 🇺🇸 Baltimore, Maryland, United States