RadiologyNCT03140306
CT Using MBIR in Crohn's Disease: Prospective Clinical Evaluation of Diagnostic Efficacy, Safety and Patient Outcome.
A study testing Patients who have had split dose CT in people with Radiology and Inflammatory Bowel Diseases, run by University College Cork at 1 site in Ireland.
Trial summary
This study aims to assess the use of low dose CT reconstructed with MBIR for the assessment of patients with inflammatory bowel disease who need CT to assess for disease complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiology, Inflammatory Bowel Diseases
- What is being tested?
- Patients who have had split dose CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteIreland
- Study dates
- 24 Oct 2017to 1 Jan 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
- Patients with inflammatory bowel disease requiring CT to assess for disease complication
Who cannot join
- Pregnancy or children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Low Dose CT Scanning of the Abdomen and Pelvis Using Model Based Iterative Reconstruction (MBIR) in Patients With Inflammatory Bowel Disease: Prospective Clinical Evaluation of Diagnostic Efficacy, Safety and Patient Outcome.
This study aims to assess the use of low dose CT reconstructed with MBIR for the assessment of patients with inflammatory bowel disease who need CT to assess for disease complications.
Read the detailed description
The purpose of this study is to clinically validate the sole use of a low-dose computed tomography (CT) protocol to reduce the cumulative radiation dose in patients with inflammatory bowel disease. In an earlier study using the same CT parameters, the efficacy of the low dose technique was confirmed in the setting of a blinded retrospective review comparing the findings of the low dose and the conventional dose scan. The purpose of this study is to determine the reliability of the using low dose scan in a prospective clinical setting
This is to be achieved using Model Based Iterative Reconstruction (MBIR) which has been shown to result in diagnostically acceptable low-dose CT imaging while providing a significant reduction of ionising radiation dose to the patient. The authors aim to apply MBIR to their low dose protocol, and to facilitate diagnostic quality CT scanning of the abdomen and pelvis at an effective dose approximately four times less than what would normally occur with an abdominopelvic CT in patients with suspected active Crohn's disease (CD).
The authors plan to assess the diagnostic efficacy, safety and patient outcome of low dose CT reconstructed with MBIR in CD patients presenting to hospital with suspected acute mural and extramural complications.
Patients with inflammatory bowel disease referred to Cork University Hospital (CUH) will undergo two series of the abdomen and pelvis: a modified low dose protocol designed to impart a radiation exposure of 10-20% that of a routine abdominal and pelvic CT and a conventional dose protocol designed to impart an effective dose of 80-90% that of a routine abdominal and pelvic CT. Using this strategy, the image quality and diagnostic yield of the low dose CT can be compared with that of the conventional dose CT and no patient will incur additional radiation exposure as a result of recruitment into the study.
The low dose scan will be read alone initially by one of two experienced radiologists and the diagnostic report will come from this data set only. This report will be placed on the Picture Archiving and Communication System (PACS) to be used by the referring clinician who will then use the report/low dose scan images for patient management. This methodology is used to ascertain the clinical efficacy in a real world setting.
One month after the initial low dose read, the two Radiologists will read the conventional dose CT scans. Note will be made on the PACS report of either agreement or discrepancy with the original low dose report. Any important discrepancy will be highlighted to the referring clinician by either phone and/or a radiological alert email.
- Conditions
- Radiology, Inflammatory Bowel Diseases
- Being tested
- Patients who have had split dose CT
- Keywords
- Computed tomography, Model based iterative reconstruction, Low dose CT
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients who have had split dose CTDiagnostic test
Computed tomography
| Study group | Role | What they receive |
|---|---|---|
| Low dose CT abdomen and pelvis | Experimental | Low dose computed tomography Receives: Diagnostic Test: Patients who have had split dose CT |
| Control dose CT abdomen and pelvis | Experimental | Control dose CT abdomen and pelvis Receives: Diagnostic Test: Patients who have had split dose CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low-dose CT scanning of the abdomen and pelvis using Model Based Iterative Reconstruction (MBIR) in patients with inflammatory bowel disease: Clinical verification study
CT study assessing efficacy of reduced dose CT compared with normal dose CT
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start24 Oct 2017
- Primary completion1 Jan 2018
- Study completion1 Jan 2019
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 RadiologyStudies 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
- Single group
- Model description
- Split dose CT
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Owen O'Connor, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140306
- Sponsor's protocol ID
- MBIR study 2
- Status last verified
- Sep 2019
- First submitted
- 2 May 2017
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Grady J, Carey BW, Kavanagh RG, O'Connell A, O'Connor OJ, Kenny-Walsh E, Zulquernain SA, Maher MM, Shanahan F. Making computed tomography safer for patients with Crohn's disease. Scand J Gastroenterol. 2022 Feb;57(2):175-182. doi: 10.1080/00365521.2021.1994640. Epub 2021 Oct 26.
PubMed 34699288
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Low Dose CT Scanning of the Abdomen and Pelvis Using Model Based Iterative Reconstruction (MBIR) in Patients With Inflammatory Bowel Disease: Prospective Clinical Evaluation of Diagnostic Efficacy, Safety and Patient Outcome.
- ClinicalTrials.gov ID
- NCT03140306
- Acronym / sponsor ID
- MBIR study 2
- Conditions
- Radiology, Inflammatory Bowel Diseases
- Keywords
- Computed tomography, Model based iterative reconstruction, Low dose CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 4 May 2017 (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.
This study aims to assess the use of low dose CT reconstructed with MBIR for the assessment of patients with inflammatory bowel disease who need CT to assess for disease complications.
Detailed description
The purpose of this study is to clinically validate the sole use of a low-dose computed tomography (CT) protocol to reduce the cumulative radiation dose in patients with inflammatory bowel disease. In an earlier study using the same CT parameters, the efficacy of the low dose technique was confirmed in the setting of a blinded retrospective review comparing the findings of the low dose and the conventional dose scan. The purpose of this study is to determine the reliability of the using low dose scan in a prospective clinical setting
This is to be achieved using Model Based Iterative Reconstruction (MBIR) which has been shown to result in diagnostically acceptable low-dose CT imaging while providing a significant reduction of ionising radiation dose to the patient. The authors aim to apply MBIR to their low dose protocol, and to facilitate diagnostic quality CT scanning of the abdomen and pelvis at an effective dose approximately four times less than what would normally occur with an abdominopelvic CT in patients with suspected active Crohn's disease (CD).
The authors plan to assess the diagnostic efficacy, safety and patient outcome of low dose CT reconstructed with MBIR in CD patients presenting to hospital with suspected acute mural and extramural complications.
Patients with inflammatory bowel disease referred to Cork University Hospital (CUH) will undergo two series of the abdomen and pelvis: a modified low dose protocol designed to impart a radiation exposure of 10-20% that of a routine abdominal and pelvic CT and a conventional dose protocol designed to impart an effective dose of 80-90% that of a routine abdominal and pelvic CT. Using this strategy, the image quality and diagnostic yield of the low dose CT can be compared with that of the conventional dose CT and no patient will incur additional radiation exposure as a result of recruitment into the study.
The low dose scan will be read alone initially by one of two experienced radiologists and the diagnostic report will come from this data set only. This report will be placed on the Picture Archiving and Communication System (PACS) to be used by the referring clinician who will then use the report/low dose scan images for patient management. This methodology is used to ascertain the clinical efficacy in a real world setting.
One month after the initial low dose read, the two Radiologists will read the conventional dose CT scans. Note will be made on the PACS report of either agreement or discrepancy with the original low dose report. Any important discrepancy will be highlighted to the referring clinician by either phone and/or a radiological alert email.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Split dose CT
| Arm | Type | Receives |
|---|---|---|
| Low dose CT abdomen and pelvis | Experimental | Diagnostic Test: Patients who have had split dose CTLow dose computed tomography |
| Control dose CT abdomen and pelvis | Experimental | Diagnostic Test: Patients who have had split dose CTControl dose CT abdomen and pelvis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with inflammatory bowel disease requiring CT to assess for disease complication
Key exclusion criteria (1 listed)
- Pregnancy or children
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 |
|---|---|---|
| Patients who have had split dose CTComputed tomography | Diagnostic test | Control dose CT abdomen and pelvis, Low dose CT abdomen and pelvis |
Primary outcome
Low-dose CT scanning of the abdomen and pelvis using Model Based Iterative Reconstruction (MBIR) in patients with inflammatory bowel disease: Clinical verification study
Time frame: 2 years
CT study assessing efficacy of reduced dose CT compared with normal dose CT
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 25 Sep 2019.
- Derived from this study: PubMed 34699288O'Grady J, Carey BW, Kavanagh RG, O'Connell A, O'Connor OJ, Kenny-Walsh E, Zulquernain SA, Maher MM, Shanahan F. Making computed tomography safer for patients with Crohn's disease. Scand J Gastroenterol. 2022 Feb;57(2):175-182. doi: 10.1080/00365521.2021.1994640. Epub 2021 Oct 26.
- Individual participant dataSharing planned: No
Related trials for Radiology
Recruiting
More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
Acute Lymphatic Leukemia, Lymphoma
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
Active, not recruitingObservational study
Development and Evaluation of Techniques for Computer Aided Detection and Diagnosis From Existing Radiologic Images
Radiology Information Systems
Not yet recruitingObservational study
Impact of a Radiologic and Immunologic Signature on Cerebral Efficacy of Treatments in Lung Cancers With Brain Metastasis
Carcinoma, Non-Small-Cell Lung
Not yet recruiting
Prostatic Artery Embolization Using Histoacryl as a Novel Embolizing Agent for Treatment of BPH
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients who have had split dose CT in people with Radiology and Inflammatory Bowel Diseases, run by University College Cork at 1 site in Ireland.
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 25 Sep 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 Ireland. 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?
Low-dose CT scanning of the abdomen and pelvis using Model Based Iterative Reconstruction (MBIR) in patients with inflammatory bowel disease: Clinical verification study (time frame: 2 years). 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 NCT03140306, 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 25 Sep 2019.