GallstoneBiliFastNCT03852836
Evaluation of MRI Sequences for Ultra-rapid Acquisition of Bile Ducts Images
A study testing ultra-rapid acquisition of bile ducts images in people with Gallstone and Cholangitis, run by IHU Strasbourg at 1 site in France.
Trial summary
The Institute of Imaged-Guided Surgery (IHU Strasbourg) has two clinical Magnetic Resonance Imaging (MRI) scanners, one with a 3T (3 Teslas) magnetic field used for diagnosis, the other with a magnetic field of 1,5T (1,5 Teslas) used for the interventional (Pre / per / postoperative). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallstone, Cholangitis, Cholangiocarcinoma
- What is being tested?
- ultra-rapid acquisition of bile ducts images
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 26 Feb 2019to 15 Sep 2021
- 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
- Male or female over 18 years old
- Patient for whom MRI is required for the diagnosis or follow-up of a pathology
- Patient able to receive and understand information related to the study and give written informed consent
- Patient affiliated to the French social security system
Who cannot join
- Patient with contraindications to MRI:
- pacemaker or automatic defibrillator, pump
- implanted
- auditory, anal, painkiller neurostimulator, etc ...
- ferromagnetic bodies in soft tissues, body
- intraocular foreigners, cerebrovascular clips
Show all 16Show fewer
- claustrophobia
- Patient presenting, in the judgment of the investigator, an illness that may prevent participation in the procedures provided by the study
- Patient who has been operated urgently
- Pregnant or lactating patient
- Patient in exclusion period (determined by a previous or a current study)
- Patient under the protection of justice
- Patient under guardianship or trusteeship
- Patient subject to a legal protection measure or out of state to express their consent
- Patient in a situation of social fragility
- A patient may be excluded at the end of the examination if at least one of the three sequences of bili-MRI could not be obtained (apnea impossible, image reconstruction problem).
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Radiologie et d'Echographie, NHC Strasbourg
Strasbourg, 67 091
About this study
The Institute of Imaged-Guided Surgery (IHU Strasbourg) has two clinical Magnetic Resonance Imaging (MRI) scanners, one with a 3T (3 Teslas) magnetic field used for diagnosis, the other with a magnetic field of 1,5T (1,5 Teslas) used for the interventional (Pre / per / postoperative).
The reference for the visualization of the biliary and pancreatic ducts is a relatively long sequence that needs a breathing-synchronized acquisition leading to artefacts on the images (blur effect).
Read more
In order to reduce and/or standardize the acquisition time as well as to limit artefacts, accelerated sequences are developed. Such sequence is available in France recently in the form of WIP Siemens (Work In Progress: sequence in test phase at manufacturer to be marketed in the short or medium term on clinical machines). It incorporates a Compressed Sensing (CS) acquisition scheme allowing the acquisition of a 3D (3 dimensions) sequence similar to the usual sequence by drastically reducing the acquisition time, the sequence CS-SPACE. This sequence exists in two forms:
- An ultra-rapid sequence acquired in apnea
- An accelerated sequence but remaining synchronized with the breath. The study carried out here on a large number of patients, with two different magnetic fields, applied routinely for diagnosis or anticipation of surgery, could be used by the community of radiologists, hepatogastroenterologists and also digestive surgeons Hepatobiliary.
Read the detailed description
The Institute of Imaged-Guided Surgery (IHU Strasbourg) has two clinical MRIs, one with a 3T (Teslas) magnetic field used for diagnosis, the other with a magnetic field of 1,5T (Teslas) used for the interventional (Pre / per / postoperative).
Cholangiopancreatography by MRI (or bili-MRI) accounts for about 25% of MRI examinations at the IHU and is used for the diagnosis of pathologies affecting the bile ducts (lithiasis pathology, cholangitis, tumoral pathology of the bile ducts) and the pancreas (search for a causal pathology to pancreatitis (calculus), ductal pathology, ductal study in tumor pathology). It can be done in preoperative context (cholecystectomy) for research of an associated calculus in the bile ducts, or for an anatomical analysis of the bile ducts (possible anatomical variants ...).
The reference for the visualization of the biliary and pancreatic ducts is a very heavily weighted T2 3D SPACE sequence. A 3D volume is obtained in which they appear in white, and the projection of this volume makes it possible to visualize the entire tract. This sequence is relatively long and needs a breathing-synchronized acquisition. The time of acquisition is then very variable from one patient to another (4 to 8 minutes). This extended acquisition time in addition to the variability of rhythm and respiratory profile can lead to artefacts on the images (blur effect). These are the limits of the respiratory synchronization that triggers acquisition by referring to the position of the liver dome which is not perfectly reproducible from a breathing cycle to the other, potentially degrading the appearance of the bile ducts and the reliability of the diagnosis.
A solution that makes it possible to reduce and / or standardize the acquisition time as well as to limit artefacts is to use an accelerated sequence. Such a sequence is available in France recently in the form of WIP Siemens (Work In Progress: sequence in test phase at manufacturer to be marketed in the short or medium term on clinical machines). It incorporates a Compressed Sensing (CS) acquisition scheme allowing the acquisition of a 3D sequence similar to the usual sequence by drastically reducing the acquisition time, the sequence CS-SPACE. This sequence exists in two forms:
- An ultra-rapid sequence acquired in apnea
- An accelerated sequence but remaining synchronized with the breath. This sequence has been shown to provide comparable, if not better, results to those obtained with the usual sequence in terms of image quality and visualization of structures, but these results were only obtained at 3T and for a reduced cohort of patients.
A lot of work is done today in the field of MRI to reduce the time of sequence acquisition. Accelerated acquisition schemes like Compressed Sensing remain marginal but are set to become the norm in the long term. The use of the sequence CS-SPACE at the IHU therefore enters into this perspective of reducing examination times.
The study carried out here on a large number of patients, with two different magnetic fields, applied routinely for diagnosis or anticipation of surgery, could be used by the community of radiologists, hepatogastroenterologists and also digestive surgeons Hepatobiliary.
- Conditions
- Gallstone, Cholangitis, Cholangiocarcinoma, Pancreatitis, Pancreatic Ductal Adenocarcinoma
- Being tested
- ultra-rapid acquisition of bile ducts images
- Keywords
- Cholangiopancreatography by MRI, Compressed Sensing
- Medical subject headings
- Gallstones, Cholangitis, Cholangiocarcinoma, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultra-rapid acquisition of bile ducts imagesOther
On top of the conventional SPACE sequence, 2 supplementary sequences will be performed with the ultra-rapid sequence (sequence CS-SPACE) either acquired in apnoea or synchronized with the breath.
| Study group | Role | What they receive |
|---|---|---|
| 1.5T magnetic field | Other | For each patient who undergo a 1.5T MRI, 3 sequences will be done: (i) a conventional SPACE sequence, (ii) an ultra-rapid sequence (sequence CS-SPACE) acquired in apnoea and (iii) an accelerated sequence (sequence CS-SPACE) but remaining synchronized with the breath. Receives: Other: ultra-rapid acquisition of bile ducts images |
| 3T magnetic field | Other | For each patient who undergo a 3T MRI, 3 sequences will be done: (i) a conventional SPACE sequence, (ii) an ultra-rapid sequence (sequence CS-SPACE) acquired in apnoea and (iii) an accelerated sequence (sequence CS-SPACE) but remaining synchronized with the breath. Receives: Other: ultra-rapid acquisition of bile ducts images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global quality of the images evaluated with a Likert score
The global Likert score corresponds to the average of scores varying between 1 and 5 and based on the following criteria :
- diagnostic quality (feasibility of establishing a diagnosis when reading the image), including canal visibility (from score 1 = no diagnostic to score 5 = Excellent) ii. the sharpness of the image, especially the canal sharpness (from score 1 = too blurry / illegible to score 5 = sharp) iii. removal of the background signal (contrast quality) (from score 1 = too much background / illegible to score 5 = no background).
The global Likert score will vary between 1 (worst) and 5 (best) as well.
Measured: 1 day: from the consent signature to the end of the exam
Secondary outcomes (4)
Comparison of the global quality of the images evaluated with a Likert score between the three sequences performed with the 1.5T MRI scanner
The sequences will be compared in pairs based on the overall image quality to determine, where appropriate, the sequence providing the best performance. The global quality of the images will be evaluated with a Likert score as described in the primary outcome measure.
The global Likert score corresponds to the average of scores varying between 1 and 5 and based on the following criteria :
- diagnostic quality (feasibility of establishing a diagnosis when reading the image), including canal visibility (from score 1 = no diagnostic to score 5 = Excellent) ii. the sharpness of the image, especially the canal sharpness (from score 1 = too blurry / illegible to score 5 = sharp) iii. removal of the background signal (contrast quality) (from score 1 = too much background / illegible to score 5 = no background).
The global Likert score will vary between 1 (worst) and 5 (best) as well.
Measured: 1 day: from the consent signature to the end of the exam
Comparison of the global quality of the images evaluated with a Likert score between the three sequences performed with the 3T MRI scanner
The sequences will be compared in pairs based on the overall image quality to determine, where appropriate, the sequence providing the best performance. The global quality of the images will be evaluated with a Likert score as described in the primary outcome measure.
The global Likert score corresponds to the average of scores varying between 1 and 5 and based on the following criteria :
- diagnostic quality (feasibility of establishing a diagnosis when reading the image), including canal visibility (from score 1 = no diagnostic to score 5 = Excellent) ii. the sharpness of the image, especially the canal sharpness (from score 1 = too blurry / illegible to score 5 = sharp) iii. removal of the background signal (contrast quality) (from score 1 = too much background / illegible to score 5 = no background).
The global Likert score will vary between 1 (worst) and 5 (best) as well.
Measured: 1 day: from the consent signature to the end of the exam
Comparison of the sequences between 1.5T and 3T MRI scanners evaluated with the Likert score
Comparison of the sequences between 1.5T and 3T MRI scanners using the Likert score in order to determine the influence of the magnetic field on the global quality of the images.
The global Likert score corresponds to the average of scores varying between 1 and 5 and based on the following criteria :
- diagnostic quality (feasibility of establishing a diagnosis when reading the image), including canal visibility (from score 1 = no diagnostic to score 5 = Excellent) ii. the sharpness of the image, especially the canal sharpness (from score 1 = too blurry / illegible to score 5 = sharp) iii. removal of the background signal (contrast quality) (from score 1 = too much background / illegible to score 5 = no background).
The global Likert score will vary between 1 (worst) and 5 (best) as well.
Measured: 1 day: from the consent signature to the end of the exam
Performance of each sequence in the visualization of the pathology and / or an anatomical variant in the 1.5T magnetic field group, evaluated in percentage
The performance is evaluated as the number of well-diagnosed patients out of the total number of cases seen at surgery in the 1.5T magnetic field group
Measured: 1 day: from the consent signature to the end of the exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start26 Feb 2019
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Why it stopped: COVID Pandemy - recruitment issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GallstoneStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanina Faucher, MD, Principal investigator, Service de Radiologie et d'Echographie, NHC Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852836
- Sponsor's protocol ID
- 18-004
- Acronym
- BiliFast
- Status last verified
- Mar 2022
- First submitted
- 21 Feb 2019
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bates DD, LeBedis CA, Soto JA, Gupta A. Use of Magnetic Resonance in Pancreaticobiliary Emergencies. Magn Reson Imaging Clin N Am. 2016 May;24(2):433-48. doi: 10.1016/j.mric.2015.11.010. Epub 2016 Feb 22.
PubMed 27150328Yoon JH, Lee SM, Kang HJ, Weiland E, Raithel E, Son Y, Kiefer B, Lee JM. Clinical Feasibility of 3-Dimensional Magnetic Resonance Cholangiopancreatography Using Compressed Sensing: Comparison of Image Quality and Diagnostic Performance. Invest Radiol. 2017 Oct;52(10):612-619. doi: 10.1097/RLI.0000000000000380.
PubMed 28448309Chandarana H, Doshi AM, Shanbhogue A, Babb JS, Bruno MT, Zhao T, Raithel E, Zenge MO, Li G, Otazo R. Three-dimensional MR Cholangiopancreatography in a Breath Hold with Sparsity-based Reconstruction of Highly Undersampled Data. Radiology. 2016 Aug;280(2):585-94. doi: 10.1148/radiol.2016151935. Epub 2016 Mar 16.
PubMed 26982678
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of MRI Sequences for Ultra-rapid Acquisition of Bile Ducts Images
- ClinicalTrials.gov ID
- NCT03852836
- Acronym / sponsor ID
- BiliFast / 18-004
- Conditions
- Gallstone, Cholangitis, Cholangiocarcinoma, Pancreatitis, Pancreatic Ductal Adenocarcinoma
- Keywords
- Cholangiopancreatography by MRI, Compressed Sensing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID Pandemy - recruitment issue
- Enrolment
- 53 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 25 Feb 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.
The Institute of Imaged-Guided Surgery (IHU Strasbourg) has two clinical Magnetic Resonance Imaging (MRI) scanners, one with a 3T (3 Teslas) magnetic field used for diagnosis, the other with a magnetic field of 1,5T (1,5 Teslas) used for the interventional (Pre / per / postoperative).
The reference for the visualization of the biliary and pancreatic ducts is a relatively long sequence that needs a breathing-synchronized acquisition leading to artefacts on the images (blur effect).
In order to reduce and/or standardize the acquisition time as well as to limit artefacts, accelerated sequences are developed. Such sequence is available in France recently in the form of WIP Siemens (Work In Progress: sequence in test phase at manufacturer to be marketed in the short or medium term on clinical machines). It incorporates a Compressed Sensing (CS) acquisition scheme allowing the acquisition of a 3D (3 dimensions) sequence similar to the usual sequence by drastically reducing the acquisition time, the sequence CS-SPACE. This sequence exists in two forms:
- An ultra-rapid sequence acquired in apnea
- An accelerated sequence but remaining synchronized with the breath. The study carried out here on a large number of patients, with two different magnetic fields, applied routinely for diagnosis or anticipation of surgery, could be used by the community of radiologists, hepatogastroenterologists and also digestive surgeons Hepatobiliary.
Detailed description
The Institute of Imaged-Guided Surgery (IHU Strasbourg) has two clinical MRIs, one with a 3T (Teslas) magnetic field used for diagnosis, the other with a magnetic field of 1,5T (Teslas) used for the interventional (Pre / per / postoperative).
Cholangiopancreatography by MRI (or bili-MRI) accounts for about 25% of MRI examinations at the IHU and is used for the diagnosis of pathologies affecting the bile ducts (lithiasis pathology, cholangitis, tumoral pathology of the bile ducts) and the pancreas (search for a causal pathology to pancreatitis (calculus), ductal pathology, ductal study in tumor pathology). It can be done in preoperative context (cholecystectomy) for research of an associated calculus in the bile ducts, or for an anatomical analysis of the bile ducts (possible anatomical variants ...).
The reference for the visualization of the biliary and pancreatic ducts is a very heavily weighted T2 3D SPACE sequence. A 3D volume is obtained in which they appear in white, and the projection of this volume makes it possible to visualize the entire tract. This sequence is relatively long and needs a breathing-synchronized acquisition. The time of acquisition is then very variable from one patient to another (4 to 8 minutes). This extended acquisition time in addition to the variability of rhythm and respiratory profile can lead to artefacts on the images (blur effect). These are the limits of the respiratory synchronization that triggers acquisition by referring to the position of the liver dome which is not perfectly reproducible from a breathing cycle to the other, potentially degrading the appearance of the bile ducts and the reliability of the diagnosis.
A solution that makes it possible to reduce and / or standardize the acquisition time as well as to limit artefacts is to use an accelerated sequence. Such a sequence is available in France recently in the form of WIP Siemens (Work In Progress: sequence in test phase at manufacturer to be marketed in the short or medium term on clinical machines). It incorporates a Compressed Sensing (CS) acquisition scheme allowing the acquisition of a 3D sequence similar to the usual sequence by drastically reducing the acquisition time, the sequence CS-SPACE. This sequence exists in two forms:
- An ultra-rapid sequence acquired in apnea
- An accelerated sequence but remaining synchronized with the breath. This sequence has been shown to provide comparable, if not better, results to those obtained with the usual sequence in terms of image quality and visualization of structures, but these results were only obtained at 3T and for a reduced cohort of patients.
A lot of work is done today in the field of MRI to reduce the time of sequence acquisition. Accelerated acquisition schemes like Compressed Sensing remain marginal but are set to become the norm in the long term. The use of the sequence CS-SPACE at the IHU therefore enters into this perspective of reducing examination times.
The study carried out here on a large number of patients, with two different magnetic fields, applied routinely for diagnosis or anticipation of surgery, could be used by the community of radiologists, hepatogastroenterologists and also digestive surgeons Hepatobiliary.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.5T magnetic field | Other | Other: ultra-rapid acquisition of bile ducts imagesFor each patient who undergo a 1.5T MRI, 3 sequences will be done: (i) a conventional SPACE sequence, (ii) an ultra-rapid sequence (sequence CS-SPACE) acquired in apnoea and (iii) an accelerated sequence (sequence CS-SPACE) but remaining synchronized with the breath. |
| 3T magnetic field | Other | Other: ultra-rapid acquisition of bile ducts imagesFor each patient who undergo a 3T MRI, 3 sequences will be done: (i) a conventional SPACE sequence, (ii) an ultra-rapid sequence (sequence CS-SPACE) acquired in apnoea and (iii) an accelerated sequence (sequence CS-SPACE) but remaining synchronized with the breath. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female over 18 years old
- Patient for whom MRI is required for the diagnosis or follow-up of a pathology
- Patient able to receive and understand information related to the study and give written informed consent
- Patient affiliated to the French social security system
Key exclusion criteria (16 listed)
- Patient with contraindications to MRI:
- Patient presenting, in the judgment of the investigator, an illness that may prevent participation in the procedures provided by the study
- Patient who has been operated urgently
- Pregnant or lactating patient
- Patient in exclusion period (determined by a previous or a current study)
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 |
|---|---|---|
| ultra-rapid acquisition of bile ducts imagesOn top of the conventional SPACE sequence, 2 supplementary sequences will be performed with the ultra-rapid sequence (sequence CS-SPACE) either acquired in apnoea or synchronized with the breath. | Other | 1.5T magnetic field, 3T magnetic field |
Primary outcome
Global quality of the images evaluated with a Likert score
Time frame: 1 day: from the consent signature to the end of the exam
The global Likert score corresponds to the average of scores varying between 1 and 5 and based on the following criteria : i. diagnostic quality (feasibility of establishing a diagnosis when reading the image), including canal visibility (from score 1 = no diagnostic to score 5 = Excellent) ii. the sharpness of the image, especially the canal sharpness (from score 1 = too blurry / illegible to score 5 = sharp) iii. removal of the background signal (contrast quality) (from score 1 = too much background / illegible to score 5 = no background). The global Likert score will vary between 1 (worst) and 5 (best) as well.
4 secondary outcomes
Comparison of the global quality of the images evaluated with a Likert score between the three sequences performed with the 1.5T MRI scanner
Time frame: 1 day: from the consent signature to the end of the exam
Comparison of the global quality of the images evaluated with a Likert score between the three sequences performed with the 3T MRI scanner
Time frame: 1 day: from the consent signature to the end of the exam
Comparison of the sequences between 1.5T and 3T MRI scanners evaluated with the Likert score
Time frame: 1 day: from the consent signature to the end of the exam
Performance of each sequence in the visualization of the pathology and / or an anatomical variant in the 1.5T magnetic field group, evaluated in percentage
Time frame: 1 day: from the consent signature to the end of the exam
Results and safety
The study was stopped early (reason given: COVID Pandemy - recruitment issue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Background: PubMed 27150328Bates DD, LeBedis CA, Soto JA, Gupta A. Use of Magnetic Resonance in Pancreaticobiliary Emergencies. Magn Reson Imaging Clin N Am. 2016 May;24(2):433-48. doi: 10.1016/j.mric.2015.11.010. Epub 2016 Feb 22.
- Background: PubMed 28448309Yoon JH, Lee SM, Kang HJ, Weiland E, Raithel E, Son Y, Kiefer B, Lee JM. Clinical Feasibility of 3-Dimensional Magnetic Resonance Cholangiopancreatography Using Compressed Sensing: Comparison of Image Quality and Diagnostic Performance. Invest Radiol. 2017 Oct;52(10):612-619. doi: 10.1097/RLI.0000000000000380.
- Background: PubMed 26982678Chandarana H, Doshi AM, Shanbhogue A, Babb JS, Bruno MT, Zhao T, Raithel E, Zenge MO, Li G, Otazo R. Three-dimensional MR Cholangiopancreatography in a Breath Hold with Sparsity-based Reconstruction of Highly Undersampled Data. Radiology. 2016 Aug;280(2):585-94. doi: 10.1148/radiol.2016151935. Epub 2016 Mar 16.
- 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.
Vanina Faucher, MD principal investigator
Service de Radiologie et d'Echographie, NHC Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultra-rapid acquisition of bile ducts images in people with Gallstone and Cholangitis, run by IHU Strasbourg at 1 site in France.
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 4 inclusion and 16 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: stopped early, as of the sponsor's last update on 6 Apr 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 France. 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 was stopped early (reason given: COVID Pandemy - recruitment issue). Results are not available in the source record.
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?
Global quality of the images evaluated with a Likert score (time frame: 1 day: from the consent signature to the end of the exam). 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 NCT03852836, which also lists 3 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 6 Apr 2022.