Status:
TERMINATED
Imaging Techniques in CT: Technical Development
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Healthy Volunteers
Eligibility:
All Genders
45+ years
Brief Summary
Background: \- Computed tomography (CT) scanning is a procedure that helps doctors with diagnoses. It uses X-ray radiation to produce an image in three dimensions. Researchers want to study how to ge...
Detailed Description
In this protocol, computed tomography (CT) imaging performed on healthy volunteers and subjects with disease will be used to test, develop and optimize CT protocols. The results of this optimization w...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- For new or healthy volunteers currently participating in an NIH trial: no CT scan in the last year OR For patients enrolled in a treatment or interventional trial at the NIH: no CT scan in the last 6 months
- Lab Eligibility parameters:
- For CT and MRI contrast enhanced scans:
- --eGFR greater than or equal to 60 mL/min/1.73m(2) within 7 days prior to scanning
- For female participants ages 45-60 within 3 days prior to scan (unless post-menopausal or no longer able to bear children, note exemption on initial visit):
- Pregnancy test result(blood or urine): Negative
- Willing to travel to the NIH for follow-up visits.
- Greater than or equal to 45 years old
- Able to understand and sign informed consent
- Stable clinical status
- Volunteer indicates no history of participation in NIH protocols using research radiation in the last 12 months (e.g. PET research scans, NCI Molecular Imaging Center PET scans, etc)
- EXCLUSION CRITERIA:
- Prior CT scan in the last 12 months for new volunteers or healthy volunteers enrolled in NIH trials OR Prior CT scan in the last 6 months for patients enrolled in a treatment or interventional trial
- Pregnant women
- Over 500 lbs and/or a body circumference that prevents the study subject from lying flat in the scanner
- Claustrophobia requiring sedation or anesthesia.
- Known or suspected genetic predisposition to cancer
- Any contraindications that the research team identifies from the subject, radiology department CT and/or MRI questionnaires, and/or History and Assessment.
- Exclusion for participation for iodinated contrast for CT
- (Inclusive of the above exclusion criteria):
- Allergy to iodinated contrast for scans (study subject will be eligible for non-contrast scans)
- Acute renal failure, renal transplant, dialysis and renal failure (clinically diagnosed).\<TAB\>
- Lactating women
- Patient preference to not undergo intravenous line placement and/or receive iodinated contrast. Contrast administration is optional and participants may still undergo a non-contrast study.
- Use of metformin-containing products less than 24 hours prior To CT contrast administration
- Other contraindications to iodinated contrast media as determined by the research team.
- Exclusion for participation for Gadolinium contrast for MRI
- (Inclusive of the above exclusion criteria):
- Allergy to gadolinium for scans using contrast; will be eligible for non-contrast scans.
- Acute renal failure, renal transplant, dialysis and renal failure individuals ( Lab Eligibility parameters and/or clinically diagnosed).\<TAB\>
- Lactating women
- Patient preference to not undergo intravenous line placement and/or receive gadolinium contrast. Contrast administration is optional and participants may still undergo a non-contrast study.
- Other contraindications to gadolinium contrast media as determined by the research team.
Exclusion
Key Trial Info
Start Date :
July 31 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 30 2019
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT02242448
Start Date
July 31 2014
End Date
October 30 2019
Last Update
December 4 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892