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

NCT ID: NCT03403361

Last Updated: 2024-03-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2022-08-11

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer Brain Cancer Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Dual-Energy CT scan

Patients enrolling in this study will undergo additional sequential DECT scan in addition to their routine SECT or DECT scan.

Group Type EXPERIMENTAL

Siemens Somatom Definition Edge

Intervention Type DEVICE

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

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clifford Robinson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

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1R01CA212638

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201711149

Identifier Type: -

Identifier Source: org_study_id

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