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

Study Overview
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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.

Official Title
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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

Conditions
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Lung Cancer, Brain Cancer

Intervention / Treatment
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* Device: Siemens Somatom Definition Edge
* Device: Philips Brilliance Big Bore CT/simulator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A: Conventional SECT<br>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 | Device: Siemens Somatom Definition Edge<br>* 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<br>Device: Philips Brilliance Big Bore CT/simulator<br>* 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<br>|
| Experimental: Arm B1: DECT<br>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 | Device: Siemens Somatom Definition Edge<br>* 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<br>Device: Philips Brilliance Big Bore CT/simulator<br>* 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<br>|
| Experimental: Arm B2: DECT<br>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 | Device: Siemens Somatom Definition Edge<br>* 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<br>Device: Philips Brilliance Big Bore CT/simulator<br>* 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<br>|
| Experimental: Arm B3: DECT<br>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 | Device: Siemens Somatom Definition Edge<br>* 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<br>Device: Philips Brilliance Big Bore CT/simulator<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3D organ-specific distribution of the DECT as measured by proton stopping powers |  | Through conclusion of radiation therapy (up to 2 years) | 
| Patient-specific distributions of the DECT as measured by proton stopping powers |  | Through conclusion of radiation therapy (up to 2 years) |