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

Primary Purpose

Lung Cancer, Brain Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Siemens Somatom Definition Edge
Philips Brilliance Big Bore CT/simulator
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Arm A: Conventional SECT

Arm B1: DECT

Arm B2: DECT

Arm B3: DECT

Arm Description

Patients enrolling in this study will undergo additional sequential DECT scans in addition to their routine single-energy computed tomography (SECT) or DECT scans In Arm A, patients are treated with treatment plans optimized and calculated on the SECT data. Plan dose is re-calculated for every patient with the clinical plan in a Monte Carlo dose calculation engine for better accuracy. The investigators will use TOPAS, an extension of Geant4 simulation toolkit, as the dose calculation engine. An additional 2 sequential scans of the thorax or head-and-neck/brain scan settings will be acquired ranging from 70-140 kVp (with or without additional filter) prior to initiating radiation therapy. Scans can be performed on the Phillips or Siemens scanners

Patients enrolling in this study will undergo additional sequential DECT scans in addition to their routine SECT or DECT scans In Arm B1, DECT data is used to estimate the actual dose delivered using the clinical plan based on SECT data. An additional 2 sequential scans of the thorax or head-and-neck/brain scan settings will be acquired ranging from 70-140 kVp (with or without additional filter) prior to initiating radiation therapy. Scans can be performed on the Phillips or Siemens scanners

Patients enrolling in this study will undergo additional sequential DECT scans in addition to their routine SECT or DECT scans In Arm B2, the plan is re-optimized on DECT data with the conventional uncertainty margin of 3.5% of proton range. An additional 2 sequential scans of the thorax or head-and-neck/brain scan settings will be acquired ranging from 70-140 kVp (with or without additional filter) prior to initiating radiation therapy. Scans can be performed on the Phillips or Siemens scanners

Patients enrolling in this study will undergo additional sequential DECT scans in addition to their routine SECT or DECT scans In Arm B3, the plan is re-optimized on DECT data with the SPR uncertainties derived from the patient-specific uncertainty model developed. An additional 2 sequential scans of the thorax or head-and-neck/brain scan settings will be acquired ranging from 70-140 kVp (with or without additional filter) prior to initiating radiation therapy. Scans can be performed on the Phillips or Siemens scanners

Outcomes

Primary Outcome Measures

3D organ-specific distribution of the DECT as measured by proton stopping powers
Patient-specific distributions of the DECT as measured by proton stopping powers

Secondary Outcome Measures

Full Information

First Posted
January 11, 2018
Last Updated
July 21, 2023
Sponsor
Washington University School of Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03403361
Brief Title
Dual-Energy CT on Plan Quality, Dose-delivery Accuracy, and Simulated Outcomes of Patients Treated With Proton or Photon Therapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
August 11, 2022 (Actual)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Brain Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Conventional SECT
Arm Type
Active Comparator
Arm Description
Patients enrolling in this study will undergo additional sequential DECT scans in addition to their routine single-energy computed tomography (SECT) or DECT scans In Arm A, patients are treated with treatment plans optimized and calculated on the SECT data. Plan dose is re-calculated for every patient with the clinical plan in a Monte Carlo dose calculation engine for better accuracy. The investigators will use TOPAS, an extension of Geant4 simulation toolkit, as the dose calculation engine. An additional 2 sequential scans of the thorax or head-and-neck/brain scan settings will be acquired ranging from 70-140 kVp (with or without additional filter) prior to initiating radiation therapy. Scans can be performed on the Phillips or Siemens scanners
Arm Title
Arm B1: DECT
Arm Type
Experimental
Arm Description
Patients enrolling in this study will undergo additional sequential DECT scans in addition to their routine SECT or DECT scans In Arm B1, DECT data is used to estimate the actual dose delivered using the clinical plan based on SECT data. An additional 2 sequential scans of the thorax or head-and-neck/brain scan settings will be acquired ranging from 70-140 kVp (with or without additional filter) prior to initiating radiation therapy. Scans can be performed on the Phillips or Siemens scanners
Arm Title
Arm B2: DECT
Arm Type
Experimental
Arm Description
Patients enrolling in this study will undergo additional sequential DECT scans in addition to their routine SECT or DECT scans In Arm B2, the plan is re-optimized on DECT data with the conventional uncertainty margin of 3.5% of proton range. An additional 2 sequential scans of the thorax or head-and-neck/brain scan settings will be acquired ranging from 70-140 kVp (with or without additional filter) prior to initiating radiation therapy. Scans can be performed on the Phillips or Siemens scanners
Arm Title
Arm B3: DECT
Arm Type
Experimental
Arm Description
Patients enrolling in this study will undergo additional sequential DECT scans in addition to their routine SECT or DECT scans In Arm B3, the plan is re-optimized on DECT data with the SPR uncertainties derived from the patient-specific uncertainty model developed. An additional 2 sequential scans of the thorax or head-and-neck/brain scan settings will be acquired ranging from 70-140 kVp (with or without additional filter) prior to initiating radiation therapy. Scans can be performed on the Phillips or Siemens scanners
Intervention Type
Device
Intervention Name(s)
Siemens Somatom Definition Edge
Intervention Description
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. These additional scans will be acquired utilizing the FDA-approved workflow and scanner operating modes. Sinogram data will be exported in raw, minimally processed form utilizing proprietary data export and processing tools provided to the investigators by the scanner vendors. In no case, will the additional local imaging dose (in terms of CTDIvol) given to the patients by the two or three additional scans exceed 6 cGy per session
Intervention Type
Device
Intervention Name(s)
Philips Brilliance Big Bore CT/simulator
Intervention Description
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. These additional scans will be acquired utilizing the FDA-approved workflow and scanner operating modes. Sinogram data will be exported in raw, minimally processed form utilizing proprietary data export and processing tools provided to the investigators by the scanner vendors. In no case, will the additional local imaging dose (in terms of CTDIvol) given to the patients by the two or three additional scans exceed 6 cGy per session
Primary Outcome Measure Information:
Title
3D organ-specific distribution of the DECT as measured by proton stopping powers
Time Frame
Through conclusion of radiation therapy (up to 2 years)
Title
Patient-specific distributions of the DECT as measured by proton stopping powers
Time Frame
Through conclusion of radiation therapy (up to 2 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clifford Robinson, M.D.
Phone
314-362-8567
Email
clifford.robinson@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clifford Robinson, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clifford Robinson, M.D.
Phone
314-362-8567
Email
clifford.robinson@wustl.edu
First Name & Middle Initial & Last Name & Degree
Clifford Robinson, M.D.
First Name & Middle Initial & Last Name & Degree
Jeffrey Williamson, Ph.D.
First Name & Middle Initial & Last Name & Degree
Tianyu Zhao, Ph.D.
First Name & Middle Initial & Last Name & Degree
Joseph O'Sullivan, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

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

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