Dose Efficiency of Modern CT Scanners in Oncologic Scans

NCT ID: NCT04989192

Last Updated: 2021-08-18

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

2400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-17

Study Completion Date

2023-08-17

Brief Summary

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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

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Conditions

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Neoplasms Neoplasm Metastasis Metastatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization of patients referred for a staging CT scan 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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CT scanner 1

Patients will undergo imaging on scanner 1.

Group Type OTHER

Scan at CT scanner 1

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 among all three arms.

CT scanner 2

Patients will undergo imaging on scanner 2.

Group Type OTHER

Scan at CT scanner 2

Intervention Type DIAGNOSTIC_TEST

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.

CT scanner 3

Patients will undergo imaging on scanner 3.

Group Type OTHER

Scan at CT scanner 3

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
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

Universitätsklinikum Augsburg

Locations

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University Hospital Augsburg

Augsburg, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Florian Schwarz, MD

Role: CONTACT

+498214002441

Facility Contacts

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Florian Schwarz, MD

Role: primary

+498214002441

References

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Risch F, Decker JA, Popp D, Sinzinger A, Braun F, Bette S, Jehs B, Haerting M, Wollny C, Scheurig-Muenkler C, Kroencke TJ, Schwarz F. Artifact Reduction From Dental Material in Photon-Counting Detector Computed Tomography Data Sets Based on High-keV Monoenergetic Imaging and Iterative Metal Artifact Reduction Reconstructions-Can We Combine the Best of Two Worlds? Invest Radiol. 2023 Sep 1;58(9):691-696. doi: 10.1097/RLI.0000000000000967.

Reference Type DERIVED
PMID: 36897803 (View on PubMed)

Other Identifiers

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21-0280

Identifier Type: -

Identifier Source: org_study_id

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