Dose Efficiency of Modern CT Scanners in Oncologic Scans

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Neoplasm Metastasis; Metastatic Cancer
• Intervention / Treatment: Diagnostic test: Scan at CT scanner 1; Diagnostic test: Scan at CT scanner 2; Diagnostic test: Scan at CT scanner 3

• Study Type: Interventional
• Enrollment (Anticipated): 2400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florian Schwarz, MD; Phone Number: +498214002441; Email: radiologie-studien@uk-augsburg.de

Study Locations

• Germany
  • Bavaria
    • Augsburg, Bavaria, Germany, 86156
      • Recruiting
      • University Hospital Augsburg
      • Contact: Florian Schwarz, MD; Phone Number: +498214002441; Email: radiologie-studien@uk-augsburg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CT scanner 1; Patients will undergo imaging on scanner 1.	Diagnostic test: Scan at CT scanner 1; 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.
Other: CT scanner 2; Patients will undergo imaging on scanner 2.	Diagnostic test: Scan at CT scanner 2; 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.
Other: CT scanner 3; Patients will undergo imaging on scanner 3.	Diagnostic test: Scan at CT scanner 3; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Augsburg
• Investigators: Principal Investigator: Florian Schwarz, MD, Universitatsklinikum Augsburg

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2021
• Primary Completion (Anticipated): August 17, 2022
• Study Completion (Anticipated): August 17, 2023

Study Registration Dates

• First Submitted: July 23, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: CT; Computed Tomography; Spectral CT; Radiation Dose; Dose Efficiency
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: 21-0280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to share individual participant data upon request (pending final approval by the data protection officer).
• IPD Sharing Time Frame: Requests for sharing individual participant data will be considered at the time of publication of the first manuscript containing result data.
• IPD Sharing Access Criteria: We plan to share data on request at this point in time.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No