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Trial record 4 of 15 for:    Recruiting, Enrolling by invitation Studies | Interventional Studies | Brain Tumor | United States | Phase Early Phase 1, 1, 2 | Start date from 02/15/2018 to 06/11/2018

Dual-Energy CT on Plan Quality, Dose-delivery Accuracy, and Simulated Patient Outcomes for Locally Advanced Lung and Brain Tumor Patients Treated With Proton Therapy

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ClinicalTrials.gov Identifier: NCT03403361
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : June 25, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Brain Cancer Device: Siemens Somatom Definition Edge Device: Philips Brilliance Big Bore CT/simulator Phase 1

Study Type : Interventional
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Virtual Clinical Trial to Assess the Impact of Dual-Energy CT on Plan Quality, Dose-delivery Accuracy, and Simulated Patient Outcomes for Locally Advanced Lung and Brain Tumor Patients Treated With Proton Therapy
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Active Comparator: Arm A: Conventional SECT
  • 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 or 3 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 proton therapy and at approximately two and four weeks after initiating therapy as well as at the conclusion of radiation therapy.
  • Scans can be performed on the Phillips or Siemens scanners
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. 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

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. 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

Experimental: Arm B1: DECT
  • 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 or 3 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 proton therapy and at approximately two and four weeks after initiating therapy as well as at the conclusion of radiation therapy.

    • Scans can be performed on the Phillips or Siemens scanners
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. 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

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. 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

Experimental: Arm B2: DECT
  • 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 or 3 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 proton therapy and at approximately two and four weeks after initiating therapy as well as at the conclusion of radiation therapy.
  • Scans can be performed on the Phillips or Siemens scanners
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. 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

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. 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

Experimental: Arm B3: DECT
  • 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 or 3 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 proton therapy and at approximately two and four weeks after initiating therapy as well as at the conclusion of radiation therapy.
  • Scans can be performed on the Phillips or Siemens scanners
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. 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

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. 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 Measures :
  1. 3D organ-specific distribution of the DECT as measured by proton stopping powers [ Time Frame: Through conclusion of radiation therapy (up to 2 years) ]
  2. Patient-specific distributions of the DECT as measured by proton stopping powers [ Time Frame: Through conclusion of radiation therapy (up to 2 years) ]

Secondary Outcome Measures :
  1. Impact of DECT tissue property mapping as measured by plan quality [ Time Frame: Through conclusion of radiation therapy (up to 2 years) ]
  2. Impact of DECT tissue property mapping as measured by dose-delivery accuracy [ Time Frame: Through conclusion of radiation therapy (up to 2 years) ]
  3. Impact of DECT tissue property mapping as measured by simulated patient outcomes [ Time Frame: Through conclusion of radiation therapy (up to 2 years) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Eligibility Criteria:

Inclusion Criteria:

  • Diagnosis of histologically proven node-positive lung cancer (n=20) OR base of skull or brain tumor (n=20).
  • Tumor(s) must be located near air cavities.
  • At least 18 years of age.
  • Karnofsky performance score of at least 80.
  • Planning to undergo proton 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.
  • IV or oral contrast medium within the week prior to enrollment.
  • Pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403361


Contacts
Contact: Jeffrey Bradley, M.D. (314) 747-1786 jbradley@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jeffrey Bradley, M.D.    314-747-1786    jbradley@wustl.edu   
Principal Investigator: Jeffrey Bradley, M.D.         
Sub-Investigator: Jeffrey Williamson, Ph.D.         
Sub-Investigator: Tianyu Zhao, Ph.D.         
Sub-Investigator: Joseph O'Sullivan, Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jeffrey Bradley, M.D. Washington University School of Medicine

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03403361     History of Changes
Other Study ID Numbers: 201711149
1R01CA212638 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases