NeoplasmsNCT04989192
Dose Efficiency of Modern CT Scanners in Oncologic Scans
A study testing Scan at CT scanner 1, Scan at CT scanner 2 and Scan at CT scanner 3 in people with Neoplasms and Neoplasm Metastasis, run by University Hospital Augsburg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Neoplasm Metastasis, Metastatic Cancer
- What is being tested?
- Scan at CT scanner 1, Scan at CT scanner 2 and Scan at CT scanner 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteGermany
- Study dates
- 17 Aug 2021to 17 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- age < 18 years
- known or suspected pregnancy
- contraindications for contrast agent (renal failure, allergy, hyperthyroidism)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Augsburg
Augsburg, Bavaria, 86156
Florian Schwarz, MD, +498214002441, radiologie-studien@uk-augsburg.de
About this study
Official title: On Dose Efficiency of Modern CT-Scanners in the Staging of Malignancies - a Prospective Randomized Study
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
- Being tested
- Scan at CT scanner 1, Scan at CT scanner 2, Scan at CT scanner 3
- Keywords
- Spectral CT, CT, Computed Tomography, Radiation Dose, Dose Efficiency
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scan at CT scanner 1Diagnostic 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.
Scan at CT scanner 2Diagnostic 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.
Scan at CT scanner 3Diagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| CT scanner 1 | Other | Patients will undergo imaging on scanner 1. Receives: Diagnostic Test: Scan at CT scanner 1 |
| CT scanner 2 | Other | Patients will undergo imaging on scanner 2. Receives: Diagnostic Test: Scan at CT scanner 2 |
| CT scanner 3 | Other | Patients will undergo imaging on scanner 3. Receives: Diagnostic Test: Scan at CT scanner 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Image Quality
measured as signal, noise and modulation transfer function equivalent parameters derived from patient scans
Measured: 1 year
Radiation Dose
measured as x-ray tube parameters such as dose length product (DLP)
Measured: 1 year
Secondary outcomes (1)
Subjective Image Quality (entire cohort and for individual disease groups)
measured by blinded evaluation by radiologists
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start17 Aug 2021
- Primary completion17 Aug 2022 (estimated)
- Study completion17 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florian Schwarz, MD, Principal investigator, Universitätsklinikum Augsburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989192
- Sponsor's protocol ID
- 21-0280
- Status last verified
- Jul 2021
- First submitted
- 23 Jul 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share individual participant data upon request (pending final approval by the data protection officer).
Publications
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.
PubMed 36897803
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On Dose Efficiency of Modern CT-Scanners in the Staging of Malignancies - a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04989192
- Acronym / sponsor ID
- 21-0280
- Conditions
- Neoplasms, Neoplasm Metastasis, Metastatic Cancer
- Keywords
- Spectral CT, CT, Computed Tomography, Radiation Dose, Dose Efficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 17 Aug 2022 (estimated)
- Study completion
- 17 Aug 2023 (estimated)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomization of patients referred for a staging CT scan one of three CT scanners routinely used for this purpose in our department
| Arm | Type | Receives |
|---|---|---|
| CT scanner 1 | Other | Diagnostic Test: Scan at CT scanner 1Patients will undergo imaging on scanner 1. |
| CT scanner 2 | Other | Diagnostic Test: Scan at CT scanner 2Patients will undergo imaging on scanner 2. |
| CT scanner 3 | Other | Diagnostic Test: Scan at CT scanner 3Patients will undergo imaging on scanner 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- age < 18 years
- known or suspected pregnancy
- contraindications for contrast agent (renal failure, allergy, hyperthyroidism)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scan at CT scanner 1Patients 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. | Diagnostic test | CT scanner 1 |
| Scan at CT scanner 2Patients 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. | Diagnostic test | CT scanner 2 |
| Scan at CT scanner 3Patients 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. | Diagnostic test | CT scanner 3 |
Primary outcome
Objective Image Quality
Time frame: 1 year
measured as signal, noise and modulation transfer function equivalent parameters derived from patient scans
Radiation Dose
Time frame: 1 year
measured as x-ray tube parameters such as dose length product (DLP)
1 secondary outcome
Subjective Image Quality (entire cohort and for individual disease groups)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Derived from this study: PubMed 36897803Risch 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.
- Individual participant dataSharing planned: Yes. We plan to share individual participant data upon request (pending final approval by the data protection officer).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Schwarz, MD principal investigator
Universitätsklinikum Augsburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scan at CT scanner 1, Scan at CT scanner 2 and Scan at CT scanner 3 in people with Neoplasms and Neoplasm Metastasis, run by University Hospital Augsburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florian Schwarz, MD (+498214002441, radiologie-studien@uk-augsburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Image Quality (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04989192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.