- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02610465
High Image Matrix CT-reconstructie
Background:
Computed Tomography (CT) scans make detailed pictures of the body in seconds. CT scans make pictures by passing x-rays through a person. CT scans are common. In 2011, around 85.3 million of them occurred in the United States. Researchers think CT images can be made better using new techniques. Higher resolution images can be derived from the original scan.
Objective:
To learn if new ways of obtaining and processing pictures of the body from a regular CT scan can produce images with higher resolution (pixels) and more information than standard methods.
Eligibility:
People ages 18 and older who are scheduled to have a CT scan and are not pregnant
Design:
Participants will be screened with a review of their medical records.
Participants will have their scheduled CT scan.
The CT scanner used in this study provides enhanced images of inside the body. Researchers may use the CT scanner in a research mode to test and improve the pictures.
Images from the CT scan will be reviewed.
Any clinical findings from the CT test will be shared with the participant s doctor.
Participants will continue to receive their medical care from their regular doctor.
The CT images will be entered into an NIH research database. In the future, they may be used for research purposes.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
Computed Tomography (CT) images the body. Different methods of creating CT pictures are avilable on a research basis that enables higher resolution imaging using the same aquisition. The purpose of this research study is to learn wheteher these new high resolution images derived from the original CT scan provide similar or perhaps more information than the current standard clinical method.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Maryland
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Bethesda, Maryland, Verenigde Staten, 20892
- National Institutes of Health Clinical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Participants will be enrolled at the NIH Clinical CenterUp to 500 subjects will be enrolled. Subjects will be recruited from the NIH Clinical Center radiology department from subjects scheduled to have a CT scan
Beschrijving
- INCLUSION CRITERIA:
- Clinical indication for CT
- Age equal to or greater than 18 years
- Able to understand and willing to sign the Informed Consent Form
EXCLUSION CRITERIA:
-Pregnancy
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: CASE_CONTROL
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
|---|
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1
Computed Tomography (CT) images |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Compare with respect to 7 image quality metrics the overall image quality from a higher resolution CT with traditional clinical standard CT from the same acquisition
Tijdsspanne: 05/13/2016
|
The primary analysis will compare the overall image quality across the 7 Likert scales between the clinical standard and the high resolution images. For each of the two readers, we will sum each subject s 7 Likert scores for the standard and high resolution images, respectively. Then we will average the two readers standard image cumulative scores, respectively, the two readers high resolution image cumulative scores. Thus for each subject, both the standard and high resolution images will have an average cumulative score between 7 and 34. For each subject, we will compute the difference between the standard image and high resolution image average cumulative scores. The primary analysis will report the mean and its 95% confidence interval for the standard image high resolution image difference. We will also report the median and 5th-95th percentiles of the differences. |
05/13/2016
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Marcus Y Chen, M.D., National Heart, Lung, and Blood Institute (NHLBI)
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Geschat)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 160019
- 16-H-0019
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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