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Dose Efficiency of Modern CT Scanners in Oncologic Scans

Primary Purpose

Neoplasms, Neoplasm Metastasis, Metastatic Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Scan at CT scanner 1

Scan at CT scanner 2

Scan at CT scanner 3

About this trial

This is an interventional diagnostic trial for Neoplasms focused on measuring Spectral CT, CT, Computed Tomography, Radiation Dose, Dose Efficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University Hospital AugsburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

CT scanner 1

CT scanner 2

CT scanner 3

Arm Description

Patients will undergo imaging on scanner 1.

Patients will undergo imaging on scanner 2.

Patients will undergo imaging on scanner 3.

Outcomes

Primary Outcome Measures

Objective Image Quality

measured as signal, noise and modulation transfer function equivalent parameters derived from patient scans

Radiation Dose

measured as x-ray tube parameters such as dose length product (DLP)

Secondary Outcome Measures

Subjective Image Quality (entire cohort and for individual disease groups)

measured by blinded evaluation by radiologists

Full Information

NCT ID

NCT04989192

First Posted

July 23, 2021

Last Updated

August 17, 2021

Sponsor

University Hospital Augsburg

1. Study Identification

Unique Protocol Identification Number

NCT04989192

Brief Title

Dose Efficiency of Modern CT Scanners in Oncologic Scans

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 17, 2021 (Actual)

Primary Completion Date

August 17, 2022 (Anticipated)

Study Completion Date

August 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital Augsburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplasms, Neoplasm Metastasis, Metastatic Cancer

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Masking Description

no masking required

Allocation

Randomized

Enrollment

2400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CT scanner 1

Arm Type

Other

Arm Description

Patients will undergo imaging on scanner 1.

Arm Title

CT scanner 2

Arm Type

Other

Arm Description

Patients will undergo imaging on scanner 2.

Arm Title

CT scanner 3

Arm Type

Other

Arm Description

Patients will undergo imaging on scanner 3.

Intervention Type

Diagnostic Test

Intervention Name(s)

Scan at CT scanner 1

Intervention Description

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

Intervention Name(s)

Scan at CT scanner 2

Intervention Description

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

Intervention Name(s)

Scan at CT scanner 3

Intervention Description

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.

Primary Outcome Measure Information:

Title

Objective Image Quality

Description

measured as signal, noise and modulation transfer function equivalent parameters derived from patient scans

Time Frame

1 year

Title

Radiation Dose

Description

measured as x-ray tube parameters such as dose length product (DLP)

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Subjective Image Quality (entire cohort and for individual disease groups)

Description

measured by blinded evaluation by radiologists

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Florian Schwarz, MD

Phone

+498214002441

radiologie-studien@uk-augsburg.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Florian Schwarz, MD

Organizational Affiliation

Universitätsklinikum Augsburg

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Augsburg

City

Augsburg

State/Province

Bavaria

ZIP/Postal Code

86156

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Florian Schwarz, MD

Phone

+498214002441

radiologie-studien@uk-augsburg.de

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

We plan to share individual participant data upon request (pending final approval by the data protection officer).

IPD Sharing Time Frame

Requests for sharing individual participant data will be considered at the time of publication of the first manuscript containing result data.

IPD Sharing Access Criteria

We plan to share data on request at this point in time.

Learn more about this trial

Dose Efficiency of Modern CT Scanners in Oncologic Scans

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