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On Dose Efficiency of Modern CT-scanners in Chest Scans

NCT ID: NCT04996693

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

958 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-07

Study Completion Date

2023-05-31

Brief Summary

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CT scans of the chest / thorax are of great importance both in the initial diagnosis and in the follow-up of pulmonary or thoracic diseases. As an example, CT angiography of the pulmonary arteries (CTPA) is worldwide considered to be gold standard test in patients with a suspicion for pulmonary embolism.

The aim of this study is to measure and compare dose efficiency of modern CT scanners for unenhanced and contrast-enhanced scan protocols of the chest/thorax. Patients who are referred for a CT of the chest/thorax will be randomly assigned to one of the three CT scanners currently in use at our institution.

Detailed Description

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Conditions

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Pneumonia Lung Cancer Pulmonary Embolism Pulmonary Disease Aortic Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization of patients referred for a CT scan of the thorax on one of three CT scanners routinely used for this purpose in our department
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

no masking required

Study Groups

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Scanner 1

Imaging performed on scanner 1: Photon-Counting Detector CT

Group Type OTHER

Imaging on Scanner with Spectral Imaging Capabilities

Intervention Type DIAGNOSTIC_TEST

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 in all three arms.

Scanner 2

Imaging performed on scanner 2: Energy-Integrating Detector CT (128-slice)

Group Type OTHER

CT Scan using an Energy-Integrating Detector CT (128 slice MDCT)

Intervention Type DIAGNOSTIC_TEST

Patients will undergo imaging on a modern 128-slice CT scanner (Siemens Healthineers) with energy-integrating detector and without spectral acquisition mode. Contrast material protocol and scan ranges are similar in all three arms.

Scanner 3

Imaging performed on scanner 3: Energy-Integrating Detector CT (20-slice)

Group Type OTHER

CT Scan using an Energy-Integrating Detector CT (20-slice MDCT)

Intervention Type DIAGNOSTIC_TEST

Patients will undergo imaging on a modern 20-slice CT scanner (Siemens Healthineers) with energy-integrating detector and without spectral acquisition mode. Contrast material protocol and scan ranges are similar in all three arms.

Interventions

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Imaging on Scanner with Spectral Imaging Capabilities

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 in all three arms.

Intervention Type DIAGNOSTIC_TEST

CT Scan using an Energy-Integrating Detector CT (128 slice MDCT)

Patients will undergo imaging on a modern 128-slice CT scanner (Siemens Healthineers) with energy-integrating detector and without spectral acquisition mode. Contrast material protocol and scan ranges are similar in all three arms.

Intervention Type DIAGNOSTIC_TEST

CT Scan using an Energy-Integrating Detector CT (20-slice MDCT)

Patients will undergo imaging on a modern 20-slice CT scanner (Siemens Healthineers) with energy-integrating detector and without spectral acquisition mode. Contrast material protocol and scan ranges are similar in all three arms.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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CT Scan using a Photon-Counting Detector CT: Naeotom Alpha (Siemens Healthineers)

Eligibility Criteria

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Inclusion Criteria

* patient is referred for an unenhanced CT OR contrast-enhanced CT of the chest/thorax confirmed by a board-certified radiologist ('justifying indication' according to German/European radiation protection law) AND
* patient is at least 18 years of age AND
* patient (is able to give informed consent and) has given informed consent.

Exclusion Criteria

* high degree of medical urgency (i.e. patient cannot be consented for iv contrast according to routine procedures)
* known or suspected pregnancy, or lactating . contraindications for contrast agent (renal failure, allergy, hyperthyroidism)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Augsburg

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florian Schwarz, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaetsklinikum Augsburg

Locations

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University Hospital Augsburg

Augsburg, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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21-0368

Identifier Type: -

Identifier Source: org_study_id