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NCT03403361 Clinical Trial

Dual-Energy CT on Plan Quality, Dose-delivery Accuracy, and Simulated Outcomes of Patients Treated With Proton or Photon Therapy

Lung Cancer Clinical Trial

Official title:
A Virtual Clinical Trial to Assess the Impact of Dual-Energy CT on Plan Quality, Dose-delivery Accuracy, and Simulated Outcomes of Patients Treated With Proton or Photon Therapy

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03403361
Other study ID # 201711149
Secondary ID 1R01CA212638
Status Terminated
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date August 11, 2022

Study information
Verified date February 2024
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this protocol is to refine the accuracy of proton beam therapy (PT) by the use of dual energy computed tomography (DECT), in conjunction with novel iterative image reconstruction algorithms, to more precisely determine the tissue properties through which the proton beam path travels.

Recruitment information / eligibility
Status Terminated
Enrollment 36
Est. completion date August 11, 2022
Est. primary completion date August 11, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Eligibility Criteria: Inclusion Criteria: - Diagnosis of histologically proven primary or metastatic cancer requiring thoracic radiation therapy OR radiation therapy to the head and neck or brain - At least 18 years of age. - Planning to undergo proton or photon beam radiation therapy as part of the clinical management of the diagnosed cancer. - Able to understand and willing to sign an IRB-approved written informed consent document. Exclusion Criteria: - Implanted metallic objects in the region to be scanned excepting dental prostheses - IV or oral contrast medium within 24 hours prior to DECT image acqusition - Pregnant.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Siemens Somatom Definition Edge
In addition to acquiring medically-routine datasets, each patient subject will be scanned sequentially at two or three different beam energies (80 or 90 kVp, 100 kVp, 120 kVp, and 140 kVp) as part of this research study.
• Philips Brilliance Big Bore CT/simulator
In addition to acquiring medically-routine datasets, each patient subject will be scanned sequentially at two or three different beam energies (80 or 90 kVp, 100 kVp, 120 kVp, and 140 kVp) as part of this research study.

Locations
Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (2)
Lead Sponsor Collaborator
Washington University School of Medicine National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dose Difference in 99% Planning Target Volume (PTV) Coverage Between Single Energy CT and Dual Energy CT Day 1
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