Dose Efficiency of Modern CT Scanners in Oncologic Scans

Study Overview
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Brief Summary
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CT-Staging is crucial for therapy planning of patients with malignancies. Dose efficiency and image quality are important parameters for these examinations. Up to now, scientific evidence of dose efficiency of modern CT scanners is mostly derived from retrospective analyses. This prospective study systematically analyzes dose efficiency and image quality of three modern CT scanners by randomization of patients who are scheduled for a CT scan to examine the status of malignancies. After giving informed consent and randomization (1:1:1), the CT scan will be performed at one of the modern CT scanners available at our department. This will allow a systematic allocation to the different scanners.

Official Title
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On Dose Efficiency of Modern CT-Scanners in the Staging of Malignancies - a Prospective Randomized Study

Conditions
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Neoplasms, Neoplasm Metastasis, Metastatic Cancer

Intervention / Treatment
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* Diagnostic Test: Scan at CT scanner 1
* Diagnostic Test: Scan at CT scanner 2
* Diagnostic Test: Scan at CT scanner 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical suspicion of a malignancy or known / confirmed malignancy AND indication for contrast-enhanced CT of the body confirmed by board-certified radiologist ('justifying indication' according to German/European radiation protection law) AND patient (is able to give informed consent and) has given informed consent. Exclusion Criteria: age < 18 years known or suspected pregnancy contraindications for contrast agent (renal failure, allergy, hyperthyroidism)

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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization of patients referred for a staging CT scan one of three CT scanners routinely used for this purpose in our department
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CT scanner 1<br>Patients will undergo imaging on scanner 1. | Diagnostic Test: Scan at CT scanner 1<br>* Patients will undergo imaging on a modern CT scanner with spectral imaging capabilities. A dose neutral spectral acquisition mode will routinely be used. Contrast material protocol and scan ranges are similar among all three arms.<br>|
| Other: CT scanner 2<br>Patients will undergo imaging on scanner 2. | Diagnostic Test: Scan at CT scanner 2<br>* Patients will undergo imaging on a modern 128 slice CT-scanner without spectral imaging capabilities. A standard acquisition protocol will be used. Contrast material protocol and scan ranges are similar among all three arms.<br>|
| Other: CT scanner 3<br>Patients will undergo imaging on scanner 3. | Diagnostic Test: Scan at CT scanner 3<br>* Patients will undergo imaging on a modern 20 slice CT-scanner without spectral imaging capabilities. A standard acquisition protocol will be used. Contrast material protocol and scan ranges are similar among all three arms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Image Quality | measured as signal, noise and modulation transfer function equivalent parameters derived from patient scans | 1 year | 
| Radiation Dose | measured as x-ray tube parameters such as dose length product (DLP) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Image Quality (entire cohort and for individual disease groups) | measured by blinded evaluation by radiologists | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spectral CT, CT, Computed Tomography, Radiation Dose, Dose Efficiency