TerminatedNot Applicable

Pilot Study of Model Based Iterative Reconstruction Using 64-Slice

Stopped: Feasibility study, sufficient amount of data collected.

United States92 participantsStarted 2011-09

Plain-language 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 to demonstrate that MBIR can improve general image quality characteristics at equivalent radiation dose levels.

Who can participate

Age range

30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evidence for reduced x-ray radiation exposure for applicable patient indications

Timeframe: Side by side comparison once both scans have been performed

Trial details

NCT IDNCT01431378

SponsorGE Healthcare

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2012-05

View on ClinicalTrials.gov More Posterior Fossa Hemorrhage trials