Radiation DosageNCT05135208
Optimized Camera-based Patient Positioning in CT
An observational study of Radiation Dosage, run by Dr. Panagiota Manava at 1 site in Germany.
Trial summary
To evaluate the effect on radiation dose using intelligent camera positioning in comparison to manual positioning by the radiology assistant. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Radiation Dosage
- How many people
- 3,118 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2021to 24 May 2022
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients of a primary care clinic
Who may be able to join
- Only patients with a clinical indication for a CT Scan
Who cannot join
- renal insufficiency, manifest hyperthyroidism and pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Radiology and Nuclear Medicine
Nuremberg, Bavaria, 90419
About this study
Official title: Optimized Camera-based Patient Positioning in CT: Impact on Radiation Exposure.
To evaluate the effect on radiation dose using intelligent camera positioning in comparison to manual positioning by the radiology assistant.
Read the detailed description
The positioning of the patient at the beginning of every CT examination has an major influence on the image quality and especially on the respective effective patient dose in the CT scan. If the patient position is closer to the X-ray tube, the patient dose increases significantly and if the vertical patient position is chosen too far away from the X-ray tube, the applied dose decreases, but also the image quality.
In a retrospective observational study, patients were examined on the CT scanner Somatom X.Cite and divided into two groups, one group was with intelligent camera positioning and the other with manual positioning.
The patients received their CT scan at the Institute Radiology and Nuclear Medicine at the Nuremberg North Hospital strictly according to the clinical indication and without influence of the study.
- Conditions
- Radiation Dosage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | patients positioned with 3D camera | |
| control group | patients positioned by experienced radiology assistants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective dose
the absorbed dose to different organs of the body
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start1 Feb 2021
- Primary completion24 May 2022
- Study completion24 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Radiation DosageStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3,118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Panagiota Manava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Panagiota Manava, Paracelsus Medical University
- Investigators
- Michael M. Lell, Prof. Dr., Study director, Department of Radiology and Nuclear Medicine, Klinikum Nuernberg, Paracelsus Medical University, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135208
- Sponsor's protocol ID
- CT_2021
- Status last verified
- Aug 2022
- First submitted
- 14 Nov 2021
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Booij R, Budde RPJ, Dijkshoorn ML, van Straten M. Accuracy of automated patient positioning in CT using a 3D camera for body contour detection. Eur Radiol. 2019 Apr;29(4):2079-2088. doi: 10.1007/s00330-018-5745-z. Epub 2018 Oct 10.
PubMed 30306328Kaasalainen T, Palmu K, Reijonen V, Kortesniemi M. Effect of patient centering on patient dose and image noise in chest CT. AJR Am J Roentgenol. 2014 Jul;203(1):123-30. doi: 10.2214/AJR.13.12028.
PubMed 24951205Saltybaeva N, Schmidt B, Wimmer A, Flohr T, Alkadhi H. Precise and Automatic Patient Positioning in Computed Tomography: Avatar Modeling of the Patient Surface Using a 3-Dimensional Camera. Invest Radiol. 2018 Nov;53(11):641-646. doi: 10.1097/RLI.0000000000000482.
PubMed 29762259Marsh RM, Silosky MS. The effects of patient positioning when interpreting CT dose metrics: A phantom study. Med Phys. 2017 Apr;44(4):1514-1524. doi: 10.1002/mp.12137. Epub 2017 Mar 17.
PubMed 28133763Dane B, O'Donnell T, Liu S, Vega E, Mohammed S, Singh V, Kapoor A, Megibow A. Radiation dose reduction, improved isocenter accuracy and CT scan time savings with automatic patient positioning by a 3D camera. Eur J Radiol. 2021 Mar;136:109537. doi: 10.1016/j.ejrad.2021.109537. Epub 2021 Jan 12.
PubMed 33454459Manava P, Galster M, Ammon J, Singer J, Lell MM, Rieger V. Optimized Camera-Based Patient Positioning in CT: Impact on Radiation Exposure. Invest Radiol. 2023 Feb 1;58(2):126-130. doi: 10.1097/RLI.0000000000000904. Epub 2022 Aug 2.
PubMed 35926075
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Camera-based Patient Positioning in CT: Impact on Radiation Exposure.
- ClinicalTrials.gov ID
- NCT05135208
- Acronym / sponsor ID
- CT_2021
- Conditions
- Radiation Dosage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,118 participants (actual)
- Lead sponsor
- Dr. Panagiota ManavaUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 26 Nov 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.
To evaluate the effect on radiation dose using intelligent camera positioning in comparison to manual positioning by the radiology assistant.
Detailed description
The positioning of the patient at the beginning of every CT examination has an major influence on the image quality and especially on the respective effective patient dose in the CT scan. If the patient position is closer to the X-ray tube, the patient dose increases significantly and if the vertical patient position is chosen too far away from the X-ray tube, the applied dose decreases, but also the image quality.
In a retrospective observational study, patients were examined on the CT scanner Somatom X.Cite and divided into two groups, one group was with intelligent camera positioning and the other with manual positioning.
The patients received their CT scan at the Institute Radiology and Nuclear Medicine at the Nuremberg North Hospital strictly according to the clinical indication and without influence of the study.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | –patients positioned with 3D camera |
| control group | – | –patients positioned by experienced radiology assistants |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients of a primary care clinic
Key inclusion criteria (1 listed)
- Only patients with a clinical indication for a CT Scan
Key exclusion criteria (1 listed)
- renal insufficiency, manifest hyperthyroidism and pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effective dose
Time frame: 10 months
the absorbed dose to different organs of the body
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Background: PubMed 30306328Booij R, Budde RPJ, Dijkshoorn ML, van Straten M. Accuracy of automated patient positioning in CT using a 3D camera for body contour detection. Eur Radiol. 2019 Apr;29(4):2079-2088. doi: 10.1007/s00330-018-5745-z. Epub 2018 Oct 10.
- Background: PubMed 24951205Kaasalainen T, Palmu K, Reijonen V, Kortesniemi M. Effect of patient centering on patient dose and image noise in chest CT. AJR Am J Roentgenol. 2014 Jul;203(1):123-30. doi: 10.2214/AJR.13.12028.
- Background: PubMed 29762259Saltybaeva N, Schmidt B, Wimmer A, Flohr T, Alkadhi H. Precise and Automatic Patient Positioning in Computed Tomography: Avatar Modeling of the Patient Surface Using a 3-Dimensional Camera. Invest Radiol. 2018 Nov;53(11):641-646. doi: 10.1097/RLI.0000000000000482.
- Background: PubMed 28133763Marsh RM, Silosky MS. The effects of patient positioning when interpreting CT dose metrics: A phantom study. Med Phys. 2017 Apr;44(4):1514-1524. doi: 10.1002/mp.12137. Epub 2017 Mar 17.
- Background: PubMed 33454459Dane B, O'Donnell T, Liu S, Vega E, Mohammed S, Singh V, Kapoor A, Megibow A. Radiation dose reduction, improved isocenter accuracy and CT scan time savings with automatic patient positioning by a 3D camera. Eur J Radiol. 2021 Mar;136:109537. doi: 10.1016/j.ejrad.2021.109537. Epub 2021 Jan 12.
- Derived from this study: PubMed 35926075Manava P, Galster M, Ammon J, Singer J, Lell MM, Rieger V. Optimized Camera-Based Patient Positioning in CT: Impact on Radiation Exposure. Invest Radiol. 2023 Feb 1;58(2):126-130. doi: 10.1097/RLI.0000000000000904. Epub 2022 Aug 2.
- Individual participant dataSharing planned: No
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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.
Michael M. Lell, Prof. Dr. study director
Department of Radiology and Nuclear Medicine, Klinikum Nuernberg, Paracelsus Medical University, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Dosage, run by Dr. Panagiota Manava 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective dose (time frame: 10 months). 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 NCT05135208, which also lists 6 linked publications.
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 1 Sep 2022.