Dose Efficiency of Modern CT Scanners in Oncologic Scans

Not Applicable

• Conditions: Neoplasms; Neoplasm Metastasis; Metastatic Cancer
• Interventions: Diagnostic Test: Scan at CT scanner 1; Diagnostic Test: Scan at CT scanner 3; Diagnostic Test: Scan at CT scanner 2

• Registration Number: NCT04989192
• Lead Sponsor: University Hospital Augsburg

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-23
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-04
• Study Start: 2021-08-17
• Last Update Submitted: 2021-08-17
• Last Update Posted: 2021-08-18
• Primary Completion: 2022-08-17
• Study Completion: 2023-08-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT scanner 1	Scan at CT scanner 1	Patients will undergo imaging on scanner 1.
CT scanner 3	Scan at CT scanner 3	Patients will undergo imaging on scanner 3.
CT scanner 2	Scan at CT scanner 2	Patients will undergo imaging on scanner 2.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Subjective Image Quality (entire cohort and for individual disease groups)	1 year	measured by blinded evaluation by radiologists

Trial Locations

Locations (1)

University Hospital Augsburg; 🇩🇪 Augsburg, Bavaria, Germany