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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04989192
Enrollment
2400
Registered
2021-08-04
Start date
2021-08-17
Completion date
2023-08-17
Last updated
2021-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Cancer, Neoplasm Metastasis, Neoplasms

Keywords

Spectral CT, CT, Computed Tomography, Radiation Dose, Dose Efficiency

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.

Interventions

DIAGNOSTIC_TESTScan 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.

DIAGNOSTIC_TESTScan 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.

DIAGNOSTIC_TESTScan 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.

Sponsors

University Hospital Augsburg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

no masking required

Intervention model description

Randomization of patients referred for a staging CT scan one of three CT scanners routinely used for this purpose in our department

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Objective Image Quality1 yearmeasured as signal, noise and modulation transfer function equivalent parameters derived from patient scans
Radiation Dose1 yearmeasured as x-ray tube parameters such as dose length product (DLP)

Secondary

MeasureTime frameDescription
Subjective Image Quality (entire cohort and for individual disease groups)1 yearmeasured by blinded evaluation by radiologists

Countries

Germany

Contacts

Primary ContactFlorian Schwarz, MD
radiologie-studien@uk-augsburg.de+498214002441

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026