4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation

Pancreatic Adenocarcinoma Clinical Trial

— GCC 1210  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764659
• Other study ID #: HP-00052534
• Status: Completed
• Start date: July 2013
• Est. completion date: October 2014

Study information

• Verified date: March 2020
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma

Intervention

Other:
• Contrast-enhanced 4D computed tomography
All enrolled patients each underwent three CT scans: a 4DCT immediately following a contrast-enhanced 3DCT and an individually optimized contrast-enhanced 4DCT.

Locations

Country	Name	City	State
United States	Ummc Msgcc	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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