Posterior Fossa HemorrhageMBIRNCT01431378
Pilot Study of Model Based Iterative Reconstruction Using 64-Slice
An observational study of Posterior Fossa Hemorrhage and Lung Cancer, run by GE Healthcare at 3 sites in United States.
Trial summary
This study is being performed to confirm that the new technique, Model-Based Iterative Reconstruction (MBIR) with reduced radiation dose can deliver equivalent image quality for CT scans compared to current techniques (Filtered Back Projection with Adaptive Statistical Iterative Reconstruction (FBP with ASiR) and also… Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Posterior Fossa Hemorrhage, Lung Cancer, Flank Pain
- How many people
- 92 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2011to Aug 2015
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Population to include women or men 30 years of age or older referred for a CT scan
Who may be able to join
- Men or Women 30 years of age or older voluntarily willing to sign an informed consent.
- Patients indicated for one of the following:
- CNS: Known or suspected pathology in the posterior fossa Thorax: Patients referred for staging of a known or suspected lung cancer Abdomen: Patients with acute flank pain and suspected urolithiasis or Abdomen: Patients with a known or suspected focal liver lesion
Who cannot join
- Subjects less than 30 years of age
- Pregnant women as confirmed by urine test or current accepted institution standard
- If IV contrast is required:
- Severe or uncontrolled allergy to iodinated contrast media
- Serum creatinine > 1.7 mg/dl or estimated glomerular filtration rate [eGFR] of <60 mg/min as recorded in medical file or by current accepted institution standard
- Unable or unwilling to provide written informed consent by self or legal guardian at the time of study enrollment
- Unstable physical condition as identified by physician
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696
Duke University Medical Center
Durham, North Carolina, 27710
Froedtert Memorial Lutheran Hospital
Miwaukee, Wisconsin, 53226-3596
About this study
Official title: Pilot Study of Model Based Iterative Reconstruction Using 64-Slice Multidetector-Row CT Datasets Obtained From the Central Nervous System, Thorax, and Abdomen
This study is being performed to confirm that the new technique, Model-Based Iterative Reconstruction (MBIR) with reduced radiation dose can deliver equivalent image quality for CT scans compared to current techniques (Filtered Back Projection with Adaptive Statistical Iterative Reconstruction (FBP with ASiR) and also to demonstrate that MBIR can improve general image quality characteristics at equivalent radiation dose levels.
Read the detailed description
See brief summary
- Keywords
- CT scan, CNS, Thorax, Abdomen, staging of a known or suspected lung cancer, suspected urolithiasis, known or suspected focal liver lesion
- Medical subject headings
- Intracranial Hemorrhages, Lung Neoplasms, Flank Pain, Urolithiasis
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 |
|---|---|---|
| CNS | CNS: Known or suspected pathology in the posterior fossa | |
| Thorax | Thorax: Patients referred for staging of a known or suspected lung cancer | |
| Abdomen 1 | Abdomen: Patients with acute flank pain and suspected urolithiasis | |
| Abdomen 2 | Abdomen: Patients with a known or suspected focal liver lesion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence for reduced x-ray radiation exposure for applicable patient indications
Ultra-low radiation dose images reconstructed with MBIR yield similar anatomic and pathologic information compared to routine radiation dose images reconstructed with Filtered Back Projection (FBP) in the central nervous system (CNS), thorax, and abdomen.
Measured: Side by side comparison once both scans have been performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2012
- Study completionAug 2015
Why it stopped: Feasibility study, sufficient amount of data collected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Fossa HemorrhageStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- American College of Radiology - Image Metrix
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431378
- Sponsor's protocol ID
- 106-2010-GES-0010
- Acronym
- MBIR
- Status last verified
- Dec 2015
- First submitted
- 7 Sep 2011
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Model Based Iterative Reconstruction Using 64-Slice Multidetector-Row CT Datasets Obtained From the Central Nervous System, Thorax, and Abdomen
- ClinicalTrials.gov ID
- NCT01431378
- Acronym / sponsor ID
- MBIR / 106-2010-GES-0010
- Keywords
- CT scan, CNS, Thorax, Abdomen, staging of a known or suspected lung cancer, suspected urolithiasis, known or suspected focal liver lesion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Feasibility study, sufficient amount of data collected.
- Enrolment
- 92 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- American College of Radiology - Image Metrix
- Study start
- Sep 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 9 Sep 2011 (estimated)
- 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 is being performed to confirm that the new technique, Model-Based Iterative Reconstruction (MBIR) with reduced radiation dose can deliver equivalent image quality for CT scans compared to current techniques (Filtered Back Projection with Adaptive Statistical Iterative Reconstruction (FBP with ASiR) and also to demonstrate that MBIR can improve general image quality characteristics at equivalent radiation dose levels.
Detailed description
See brief summary
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CNS | – | –CNS: Known or suspected pathology in the posterior fossa |
| Thorax | – | –Thorax: Patients referred for staging of a known or suspected lung cancer |
| Abdomen 1 | – | –Abdomen: Patients with acute flank pain and suspected urolithiasis |
| Abdomen 2 | – | –Abdomen: Patients with a known or suspected focal liver lesion |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Population to include women or men 30 years of age or older referred for a CT scan
Key inclusion criteria (3 listed)
- Men or Women 30 years of age or older voluntarily willing to sign an informed consent.
- Patients indicated for one of the following:
- CNS: Known or suspected pathology in the posterior fossa Thorax: Patients referred for staging of a known or suspected lung cancer Abdomen: Patients with acute flank pain and suspected urolithiasis or Abdomen: Patients with a known or suspected focal liver lesion
Key exclusion criteria (7 listed)
- Subjects less than 30 years of age
- Pregnant women as confirmed by urine test or current accepted institution standard
- If IV contrast is required:
- Severe or uncontrolled allergy to iodinated contrast media
- Serum creatinine > 1.7 mg/dl or estimated glomerular filtration rate [eGFR] of <60 mg/min as recorded in medical file or by current accepted institution standard
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
Evidence for reduced x-ray radiation exposure for applicable patient indications
Time frame: Side by side comparison once both scans have been performed
Ultra-low radiation dose images reconstructed with MBIR yield similar anatomic and pathologic information compared to routine radiation dose images reconstructed with Filtered Back Projection (FBP) in the central nervous system (CNS), thorax, and abdomen.
Results and safety
The study was stopped early (reason given: Feasibility study, sufficient amount of data collected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posterior Fossa Hemorrhage and Lung Cancer, run by GE Healthcare at 3 sites in United States.
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 7 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 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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: Feasibility study, sufficient amount of data collected.). 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?
Evidence for reduced x-ray radiation exposure for applicable patient indications (time frame: Side by side comparison once both scans have been performed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2015.