Dose Efficiency of Modern CT Scanners in Oncologic Scans

NCT04989192 | Unknown

• 1 other identifier: 21-0280
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Neoplasm Metastasis; Metastatic Cancer

Keywords

Spectral CT; CT; Computed Tomography; Radiation Dose; Dose Efficiency

Outcome Measures

Primary Outcomes (2)

• Objective Image Quality

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

  1 year

• Radiation Dose

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

  1 year

Secondary Outcomes (1)

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

  1 year

Study Arms (3)

CT scanner 1

OTHER

Patients will undergo imaging on scanner 1.

Diagnostic Test: Scan at CT scanner 1

CT scanner 2

OTHER

Patients will undergo imaging on scanner 2.

Diagnostic Test: Scan at CT scanner 2

CT scanner 3

OTHER

Patients will undergo imaging on scanner 3.

Diagnostic Test: Scan at CT scanner 3

Interventions

Scan at CT scanner 1 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 1

Scan at CT scanner 2 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 2

Scan at CT scanner 3 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.

CT scanner 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• age \< 18 years
• known or suspected pregnancy
• contraindications for contrast agent (renal failure, allergy, hyperthyroidism)

Sponsors & Collaborators

• University Hospital Augsburg: lead

Study Sites (1)

University Hospital Augsburg

Augsburg, Bavaria, 86156, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 36897803 DERIVED

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Florian Schwarz, MD

  Universitätsklinikum Augsburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian Schwarz, MD

CONTACT

+498214002441; radiologie-studien@uk-augsburg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no masking required
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 4, 2021
• Study Start: August 17, 2021
• Primary Completion: August 17, 2022
• Study Completion: August 17, 2023
• Last Updated: August 18, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Requests for sharing individual participant data will be considered at the time of publication of the first manuscript containing result data.
• Access Criteria: We plan to share data on request at this point in time.

Locations

DE (1)