Pulmonary Nodule, SolitaryCoffee BreakNCT04209972
The Benefit of UHR-CT: Precision of Repeated Volume Measurements of Pulmonary Nodules
A study testing Precision Ultra-High-Resolution CT scanner and Genesis high-end CT scanner in people with Pulmonary Nodule, Solitary, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
To assess the variability of semi-automated volume measurements of pulmonary nodules on same-day repeated scans of equal radiation dose from two different CT scanners: One high-end CT scanner with standard spatial resolution (CT1) and one UHRCT scanner (CT2), in patients with known or suspected pulmonary metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Nodule, Solitary
- What is being tested?
- Precision Ultra-High-Resolution CT scanner and Genesis high-end CT scanner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Mar 2019to 30 Jul 2019
- 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
- 18 years of age or older
- A solid primary tumour anywhere in the body and solid, noncalcified nodules in the pulmonary parenchyma on previous CT scans suspected for pulmonary metastases, according to radiological reports
- Two lung nodules that do not abut vessels or pleura with a two dimensional diameter between 5 and 10 mm within a distance of each other of 16 cm in the craniocaudal direction
Who cannot join
- Immobility (not able to stand up and get off the scanner table)
- Patients who received local pulmonary treatment: Radiotherapy, Excision, Ablation
- Patients with radiologically suspected lymphangitis carcinomatosa or consolidations around the nodules.
- Patients who only have calcified pulmonary nodules or nodules that abut vessels or pleura.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Benefit of Ultra-high Resolution Computed Tomography: Precision of Repeated Volume Measurements of Pulmonary Nodules
To assess the variability of semi-automated volume measurements of pulmonary nodules on same-day repeated scans of equal radiation dose from two different CT scanners: One high-end CT scanner with standard spatial resolution (CT1) and one UHRCT scanner (CT2), in patients with known or suspected pulmonary metastases.
Read the detailed description
Rationale: Ultra-high resolution computed tomography (UHRCT) produces radiological images with a spatial resolution of 0.25 mm in a matrix of 1024x1024. This should decrease measurement variation of nodule growth as a marker of malignancy, by making nodule delineation more precise for automatic volumetry segmentation and volume doubling time assessment than in conventional CT. If possible, this can shorten follow up of incidental pulmonary nodules to exclude malignancy, with less medicalisation and patient anxiety.
Objective: To assess the variability of semi-automated volume measurements of pulmonary nodules in patients with known or suspected pulmonary metastases on same-day repeated scans of equal radiation dose from two different CT scanners: CT scanner with standard spatial resolution (conventional CT, CT1) and UHRCT (CT2).
Study design: This is a single center prospective trial on 80 patients with known or suspected pulmonary metastases who are scheduled for chest and/or abdominal CT. Study participants will undergo two additional partial chest CT scans on either CT 1 or CT 2 for research purpose only, at similar radiation dose. Patients are equally divided across CT 1 and 2.
Study population: Patients who are 18 years or older with known solid pulmonary nodules compatible with metastases and who are willing and able to give informed consent are eligible. Patients are excluded if they have less than two eligible pulmonary nodules with a z range of 16 cm. Nodules with calcifications, surrounding opacities, or vessel- or pleural abutment will be excluded from analysis.
Main study parameters/endpoints: The main endpoint of this study is the upper limit of the 95% confidence interval of repeated semi-automated nodule volume measurements of both CT scanners.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
CT imaging is associated with risks related to the use of ionizing radiation. The CT protocol including the scheduled CT scan and the additional scans in this study has been carefully designed to have a total radiation dose at the same level as the achievable diagnostic reference level of chest CT in the Netherlands, which is 542 mGycm in 2013 (1). The burden associated with the two extra study CT acquisitions comprises a dose length product (DLP) of 120.4 mGy•cm for research (1.7 mSv, which is lower than the background radiation of one year in the Netherlands, with a conversion factor of 0.014 from Deak et al (2)).
- Conditions
- Pulmonary Nodule, Solitary
- Being tested
- Precision Ultra-High-Resolution CT scanner, Genesis high-end CT scanner
- Keywords
- Ultra-high resolution CT, volume measumerents
- Medical subject headings
- Solitary Pulmonary Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision Ultra-High-Resolution CT scannerDevice
Patients will be divided on one of the two CT scanners. This group will be scanned on the Precision CT scanner.
Genesis high-end CT scannerDevice
Patients will be divided on one of the two CT scanners. This group will be scanned on the Aquilion one Genesis.
| Study group | Role | What they receive |
|---|---|---|
| Patients on CT1 | Active comparator | Patients will undergo two pre-contrast scans, and will be in between the two scans be off and on the table at a standard CT scanner. (Aquilion One Genesis, Canon Medical Systems) Receives: Device: Genesis high-end CT scanner |
| Patients on CT2 | Active comparator | Patients will undergo two pre-contrast scans, and will be in between the two scans be off and on the table at a UHRCT scanner. (Aquilion One Precision, Canon Medical Systems) Receives: Device: Precision Ultra-High-Resolution CT scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main endpoint of this study is the difference in precision in millimeter between the two CT scanners.
The precision of each scanner is obtained by the standard deviation between the two measurements. The difference between scanners is tested with an F-test and the precision of each scanner is shown by a Bland-Altman plot
Measured: 4 months
Secondary outcomes (2)
Evaluation of image quality (segmentation errors)
Evaluate the image quality of the scans
Measured: 5 months
Evaluation of image quality (motion artefacts)
Evaluate the image quality of the scans
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start11 Mar 2019
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Nodule, SolitaryStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- 2 groups, 40 patients on one CT scanner, 40 different patients on the other CT scanner.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monique Brink, PhD, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209972
- Sponsor's protocol ID
- NL67905.091.18
- Acronym
- Coffee Break
- Status last verified
- Mar 2019
- First submitted
- 20 Mar 2019
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet
Publications
van der Molen AJ, Schilham A, Stoop P, Prokop M, Geleijns J. A national survey on radiation dose in CT in The Netherlands. Insights Imaging. 2013 Jun;4(3):383-90. doi: 10.1007/s13244-013-0253-9. Epub 2013 May 15.
PubMed 23673455Deak PD, Smal Y, Kalender WA. Multisection CT protocols: sex- and age-specific conversion factors used to determine effective dose from dose-length product. Radiology. 2010 Oct;257(1):158-66. doi: 10.1148/radiol.10100047.
PubMed 20851940Alpert JB, Ko JP. Management of Incidental Lung Nodules: Current Strategy and Rationale. Radiol Clin North Am. 2018 May;56(3):339-351. doi: 10.1016/j.rcl.2018.01.002. Epub 2018 Mar 7.
PubMed 29622070MacMahon H, Naidich DP, Goo JM, Lee KS, Leung ANC, Mayo JR, Mehta AC, Ohno Y, Powell CA, Prokop M, Rubin GD, Schaefer-Prokop CM, Travis WD, Van Schil PE, Bankier AA. Guidelines for Management of Incidental Pulmonary Nodules Detected on CT Images: From the Fleischner Society 2017. Radiology. 2017 Jul;284(1):228-243. doi: 10.1148/radiol.2017161659. Epub 2017 Feb 23.
PubMed 28240562Baldwin DR, Callister ME; Guideline Development Group. The British Thoracic Society guidelines on the investigation and management of pulmonary nodules. Thorax. 2015 Aug;70(8):794-8. doi: 10.1136/thoraxjnl-2015-207221. Epub 2015 Jul 1.
PubMed 26135833Devaraj A, van Ginneken B, Nair A, Baldwin D. Use of Volumetry for Lung Nodule Management: Theory and Practice. Radiology. 2017 Sep;284(3):630-644. doi: 10.1148/radiol.2017151022.
PubMed 28825886Wormanns D, Kohl G, Klotz E, Marheine A, Beyer F, Heindel W, Diederich S. Volumetric measurements of pulmonary nodules at multi-row detector CT: in vivo reproducibility. Eur Radiol. 2004 Jan;14(1):86-92. doi: 10.1007/s00330-003-2132-0. Epub 2003 Nov 13.
PubMed 14615902Gietema HA, Schaefer-Prokop CM, Mali WP, Groenewegen G, Prokop M. Pulmonary nodules: Interscan variability of semiautomated volume measurements with multisection CT-- influence of inspiration level, nodule size, and segmentation performance. Radiology. 2007 Dec;245(3):888-94. doi: 10.1148/radiol.2452061054. Epub 2007 Oct 8.
PubMed 17923508Goodman LR, Gulsun M, Washington L, Nagy PG, Piacsek KL. Inherent variability of CT lung nodule measurements in vivo using semiautomated volumetric measurements. AJR Am J Roentgenol. 2006 Apr;186(4):989-94. doi: 10.2214/AJR.04.1821.
PubMed 16554568Hein PA, Romano VC, Rogalla P, Klessen C, Lembcke A, Bornemann L, Dicken V, Hamm B, Bauknecht HC. Variability of semiautomated lung nodule volumetry on ultralow-dose CT: comparison with nodule volumetry on standard-dose CT. J Digit Imaging. 2010 Feb;23(1):8-17. doi: 10.1007/s10278-008-9157-5. Epub 2008 Sep 5.
PubMed 18773240Han D, Heuvelmans MA, Oudkerk M. Volume versus diameter assessment of small pulmonary nodules in CT lung cancer screening. Transl Lung Cancer Res. 2017 Feb;6(1):52-61. doi: 10.21037/tlcr.2017.01.05.
PubMed 28331824Tanaka R, Yoshioka K, Takagi H, Schuijf JD, Arakita K. Novel developments in non-invasive imaging of peripheral arterial disease with CT: experience with state-of-the-art, ultra-high-resolution CT and subtraction imaging. Clin Radiol. 2019 Jan;74(1):51-58. doi: 10.1016/j.crad.2018.03.002. Epub 2018 Apr 5.
PubMed 29627067Zhou W, Montoya J, Gutjahr R, Ferrero A, Halaweish A, Kappler S, McCollough C, Leng S. Lung Nodule Volume Quantification and Shape Differentiation with an Ultra-High Resolution Technique on a Photon Counting Detector CT System. Proc SPIE Int Soc Opt Eng. 2017 Feb 11;10132:101323Q. doi: 10.1117/12.2255736. Epub 2017 Mar 9.
PubMed 28392613de Hoop B, Gietema H, van Ginneken B, Zanen P, Groenewegen G, Prokop M. A comparison of six software packages for evaluation of solid lung nodules using semi-automated volumetry: what is the minimum increase in size to detect growth in repeated CT examinations. Eur Radiol. 2009 Apr;19(4):800-8. doi: 10.1007/s00330-008-1229-x. Epub 2008 Nov 19.
PubMed 19018537Leng S, Gutjahr R, Ferrero A, Kappler S, Henning A, Halaweish A, Zhou W, Montoya J, McCollough C. Ultra-High Spatial Resolution, Multi-Energy CT using Photon Counting Detector Technology. Proc SPIE Int Soc Opt Eng. 2017 Feb 11;10132:101320Y. doi: 10.1117/12.2255589. Epub 2017 Mar 9.
PubMed 28392615
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefit of Ultra-high Resolution Computed Tomography: Precision of Repeated Volume Measurements of Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT04209972
- Acronym / sponsor ID
- Coffee Break / NL67905.091.18
- Conditions
- Pulmonary Nodule, Solitary
- Keywords
- Ultra-high resolution CT, volume measumerents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 24 Dec 2019 (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 assess the variability of semi-automated volume measurements of pulmonary nodules on same-day repeated scans of equal radiation dose from two different CT scanners: One high-end CT scanner with standard spatial resolution (CT1) and one UHRCT scanner (CT2), in patients with known or suspected pulmonary metastases.
Detailed description
Rationale: Ultra-high resolution computed tomography (UHRCT) produces radiological images with a spatial resolution of 0.25 mm in a matrix of 1024x1024. This should decrease measurement variation of nodule growth as a marker of malignancy, by making nodule delineation more precise for automatic volumetry segmentation and volume doubling time assessment than in conventional CT. If possible, this can shorten follow up of incidental pulmonary nodules to exclude malignancy, with less medicalisation and patient anxiety.
Objective: To assess the variability of semi-automated volume measurements of pulmonary nodules in patients with known or suspected pulmonary metastases on same-day repeated scans of equal radiation dose from two different CT scanners: CT scanner with standard spatial resolution (conventional CT, CT1) and UHRCT (CT2).
Study design: This is a single center prospective trial on 80 patients with known or suspected pulmonary metastases who are scheduled for chest and/or abdominal CT. Study participants will undergo two additional partial chest CT scans on either CT 1 or CT 2 for research purpose only, at similar radiation dose. Patients are equally divided across CT 1 and 2.
Study population: Patients who are 18 years or older with known solid pulmonary nodules compatible with metastases and who are willing and able to give informed consent are eligible. Patients are excluded if they have less than two eligible pulmonary nodules with a z range of 16 cm. Nodules with calcifications, surrounding opacities, or vessel- or pleural abutment will be excluded from analysis.
Main study parameters/endpoints: The main endpoint of this study is the upper limit of the 95% confidence interval of repeated semi-automated nodule volume measurements of both CT scanners.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
CT imaging is associated with risks related to the use of ionizing radiation. The CT protocol including the scheduled CT scan and the additional scans in this study has been carefully designed to have a total radiation dose at the same level as the achievable diagnostic reference level of chest CT in the Netherlands, which is 542 mGycm in 2013 (1). The burden associated with the two extra study CT acquisitions comprises a dose length product (DLP) of 120.4 mGy•cm for research (1.7 mSv, which is lower than the background radiation of one year in the Netherlands, with a conversion factor of 0.014 from Deak et al (2)).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 groups, 40 patients on one CT scanner, 40 different patients on the other CT scanner.
| Arm | Type | Receives |
|---|---|---|
| Patients on CT1 | Active comparator | Device: Genesis high-end CT scannerPatients will undergo two pre-contrast scans, and will be in between the two scans be off and on the table at a standard CT scanner. (Aquilion One Genesis, Canon Medical Systems) |
| Patients on CT2 | Active comparator | Device: Precision Ultra-High-Resolution CT scannerPatients will undergo two pre-contrast scans, and will be in between the two scans be off and on the table at a UHRCT scanner. (Aquilion One Precision, Canon Medical Systems) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- A solid primary tumour anywhere in the body and solid, noncalcified nodules in the pulmonary parenchyma on previous CT scans suspected for pulmonary metastases, according to radiological reports
- Two lung nodules that do not abut vessels or pleura with a two dimensional diameter between 5 and 10 mm within a distance of each other of 16 cm in the craniocaudal direction
Key exclusion criteria (4 listed)
- Immobility (not able to stand up and get off the scanner table)
- Patients who received local pulmonary treatment: Radiotherapy, Excision, Ablation
- Patients with radiologically suspected lymphangitis carcinomatosa or consolidations around the nodules.
- Patients who only have calcified pulmonary nodules or nodules that abut vessels or pleura.
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 |
|---|---|---|
| Precision Ultra-High-Resolution CT scannerPatients will be divided on one of the two CT scanners. This group will be scanned on the Precision CT scanner. | Device | Patients on CT2 |
| Genesis high-end CT scannerPatients will be divided on one of the two CT scanners. This group will be scanned on the Aquilion one Genesis. | Device | Patients on CT1 |
Primary outcome
The main endpoint of this study is the difference in precision in millimeter between the two CT scanners.
Time frame: 4 months
The precision of each scanner is obtained by the standard deviation between the two measurements. The difference between scanners is tested with an F-test and the precision of each scanner is shown by a Bland-Altman plot
2 secondary outcomes
Evaluation of image quality (segmentation errors)
Time frame: 5 months
Evaluation of image quality (motion artefacts)
Time frame: 5 months
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 24 Dec 2019.
- Results publication: PubMed 23673455van der Molen AJ, Schilham A, Stoop P, Prokop M, Geleijns J. A national survey on radiation dose in CT in The Netherlands. Insights Imaging. 2013 Jun;4(3):383-90. doi: 10.1007/s13244-013-0253-9. Epub 2013 May 15.
- Results publication: PubMed 20851940Deak PD, Smal Y, Kalender WA. Multisection CT protocols: sex- and age-specific conversion factors used to determine effective dose from dose-length product. Radiology. 2010 Oct;257(1):158-66. doi: 10.1148/radiol.10100047.
- Results publication: PubMed 29622070Alpert JB, Ko JP. Management of Incidental Lung Nodules: Current Strategy and Rationale. Radiol Clin North Am. 2018 May;56(3):339-351. doi: 10.1016/j.rcl.2018.01.002. Epub 2018 Mar 7.
- Results publication: PubMed 28240562MacMahon H, Naidich DP, Goo JM, Lee KS, Leung ANC, Mayo JR, Mehta AC, Ohno Y, Powell CA, Prokop M, Rubin GD, Schaefer-Prokop CM, Travis WD, Van Schil PE, Bankier AA. Guidelines for Management of Incidental Pulmonary Nodules Detected on CT Images: From the Fleischner Society 2017. Radiology. 2017 Jul;284(1):228-243. doi: 10.1148/radiol.2017161659. Epub 2017 Feb 23.
- Results publication: PubMed 26135833Baldwin DR, Callister ME; Guideline Development Group. The British Thoracic Society guidelines on the investigation and management of pulmonary nodules. Thorax. 2015 Aug;70(8):794-8. doi: 10.1136/thoraxjnl-2015-207221. Epub 2015 Jul 1.
- Results publication: PubMed 28825886Devaraj A, van Ginneken B, Nair A, Baldwin D. Use of Volumetry for Lung Nodule Management: Theory and Practice. Radiology. 2017 Sep;284(3):630-644. doi: 10.1148/radiol.2017151022.
- Results publication: PubMed 14615902Wormanns D, Kohl G, Klotz E, Marheine A, Beyer F, Heindel W, Diederich S. Volumetric measurements of pulmonary nodules at multi-row detector CT: in vivo reproducibility. Eur Radiol. 2004 Jan;14(1):86-92. doi: 10.1007/s00330-003-2132-0. Epub 2003 Nov 13.
- Results publication: PubMed 17923508Gietema HA, Schaefer-Prokop CM, Mali WP, Groenewegen G, Prokop M. Pulmonary nodules: Interscan variability of semiautomated volume measurements with multisection CT-- influence of inspiration level, nodule size, and segmentation performance. Radiology. 2007 Dec;245(3):888-94. doi: 10.1148/radiol.2452061054. Epub 2007 Oct 8.
- Results publication: PubMed 16554568Goodman LR, Gulsun M, Washington L, Nagy PG, Piacsek KL. Inherent variability of CT lung nodule measurements in vivo using semiautomated volumetric measurements. AJR Am J Roentgenol. 2006 Apr;186(4):989-94. doi: 10.2214/AJR.04.1821.
- Results publication: PubMed 18773240Hein PA, Romano VC, Rogalla P, Klessen C, Lembcke A, Bornemann L, Dicken V, Hamm B, Bauknecht HC. Variability of semiautomated lung nodule volumetry on ultralow-dose CT: comparison with nodule volumetry on standard-dose CT. J Digit Imaging. 2010 Feb;23(1):8-17. doi: 10.1007/s10278-008-9157-5. Epub 2008 Sep 5.
- Results publication: PubMed 28331824Han D, Heuvelmans MA, Oudkerk M. Volume versus diameter assessment of small pulmonary nodules in CT lung cancer screening. Transl Lung Cancer Res. 2017 Feb;6(1):52-61. doi: 10.21037/tlcr.2017.01.05.
- Results publication: PubMed 29627067Tanaka R, Yoshioka K, Takagi H, Schuijf JD, Arakita K. Novel developments in non-invasive imaging of peripheral arterial disease with CT: experience with state-of-the-art, ultra-high-resolution CT and subtraction imaging. Clin Radiol. 2019 Jan;74(1):51-58. doi: 10.1016/j.crad.2018.03.002. Epub 2018 Apr 5.
- Individual participant dataSharing planned: Undecided. Not decided yet
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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.
Monique Brink, PhD, MD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precision Ultra-High-Resolution CT scanner and Genesis high-end CT scanner in people with Pulmonary Nodule, Solitary, run by Radboud University Medical Center at 1 site in Netherlands.
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 4 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 24 Dec 2019. 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 Netherlands. 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?
The main endpoint of this study is the difference in precision in millimeter between the two CT scanners. (time frame: 4 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 NCT04209972, which also lists 17 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 24 Dec 2019.