Dose Efficiency of Modern CT Scanners in Oncologic Scans

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04989192
• Other study ID #: 21-0280
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2021
• Est. completion date: August 17, 2023

Study information

• Verified date: July 2021
• Source: University Hospital Augsburg
• Contact: Florian Schwarz, MD
• Phone: +498214002441
• Email: radiologie-studien[@]uk-augsburg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: August 17, 2023
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Germany	University Hospital Augsburg	Augsburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Augsburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Image Quality	measured as signal, noise and modulation transfer function equivalent parameters derived from patient scans	1 year
Primary	Radiation Dose	measured as x-ray tube parameters such as dose length product (DLP)	1 year
Secondary	Subjective Image Quality (entire cohort and for individual disease groups)	measured by blinded evaluation by radiologists	1 year