4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation

NCT01764659 | Completed Results DMC

• 1 other identifier: HP-00052534
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Adenocarcinoma

Keywords

4D-CT; Contrast Enhanced CT; Radiotherapy Simulation

Outcome Measures

Primary Outcomes (1)

• Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation

  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.

  1 year

Study Arms (1)

All enrolled patients

Contrast-enhanced 4D computed tomography

Other: Contrast-enhanced 4D computed tomography

Interventions

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.

All enrolled patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

GI/GU multi-d clinic

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Ummc Msgcc

Baltimore, Maryland, 21201, United States

Location

Results Point of Contact

• Title: Howard Zhang, PhD
• Organization: UMMC MSGCC

hzhang@umm.edu

(410)706-6510

Study Officials

• Wei Lu, Ph. D., DABR

  UMMC MSGCC

  PRINCIPAL INVESTIGATOR

• Hao H Zhang, Ph. D.

  UMMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Physics

Study Record Dates

• First Submitted: January 2, 2013
• First Posted: January 9, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 27, 2020
• Results First Posted: March 27, 2020

Record last verified: 2020-03

Locations

US (1)