Healthy VolunteersNCT02242448
Imaging Techniques in CT: Technical Development
An observational study of Healthy Volunteers, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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 get the best quality CT scans using the lowest possible radiation dose. Objective: To determine how to improve CT scanning. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2014to 30 Oct 2019
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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.
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- (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.
- (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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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 get the best quality CT scans using the lowest possible radiation dose.
Read more
Objective:
- To determine how to improve CT scanning.
Eligibility:
- Adults 45 years of age and older who have not had a CT scan in the past year and do not have kidney disease.
Design:
- Participants will be screened with a medical history and blood and urine tests.
- Nurses will put an intravenous (IV) line into an arm or hand vein. It will stay in for several hours during the magnetic resonance imaging (MRI) and CT scans. Through this IV, blood will be taken, dye will be injected, and medicine will be given.
- Participants may have a CT scan of the heart, head, chest, abdomen, and/or pelvis. Participants will lie on their back on a table. The table will slide into a donut-shaped machine. An X-ray tube will move around the body, taking pictures.
- Participants may be given a drug called a beta blocker by mouth or through the IV tube.
- Participants heart rate and blood pressure will be monitored.
- Participants may have an MRI scan. The MRI is a large hollow tube. The participant will lie on a table that will be moved into the tube, which contains a magnetic field. When the imaging starts, a thumping sound will be heard. Headphones or earplugs will be provided to muffle the sound.
- Participants will give blood samples.
Read the 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 will be used to evaluate the performance of new imaging methods and equipment, and to provide essential ground work for research and development for use in future patient CT studies. CT imaging is a noninvasive technology. As appropriate, MRI scans will be used to compare to CT imaging findings to help validate the CT methods.
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteer, Contrast
What is being measured
The primary outcome is the main question the study is designed to answer.
To enhance imaging quality and safety
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study start31 Jul 2014
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David A Bluemke, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242448
- Sponsor's protocol ID
- 140158
- Other IDs
- 14-CC-0158
- Status last verified
- 30 Oct 2019
- First submitted
- 31 Jul 2014
- Last updated
- 4 Dec 2019
- Results posted
- No
Publications
Halliburton S, Arbab-Zadeh A, Dey D, Einstein AJ, Gentry R, George RT, Gerber T, Mahesh M, Weigold WG. State-of-the-art in CT hardware and scan modes for cardiovascular CT. J Cardiovasc Comput Tomogr. 2012 May-Jun;6(3):154-63. doi: 10.1016/j.jcct.2012.04.005. Epub 2012 Apr 7.
PubMed 22551595Trattner S, Pearson GDN, Chin C, Cody DD, Gupta R, Hess CP, Kalra MK, Kofler JM Jr, Krishnam MS, Einstein AJ. Standardization and optimization of CT protocols to achieve low dose. J Am Coll Radiol. 2014 Mar;11(3):271-278. doi: 10.1016/j.jacr.2013.10.016.
PubMed 24589403Mahesh M. Variability in CT protocols. J Am Coll Radiol. 2013 Oct;10(10):805-6. doi: 10.1016/j.jacr.2013.07.005. Epub 2013 Aug 26. No abstract available.
PubMed 23988585
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Techniques in CT: Technical Development
- ClinicalTrials.gov ID
- NCT02242448
- Acronym / sponsor ID
- 140158
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteer, Contrast
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 109 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 31 Jul 2014
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 17 Sep 2014 (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.
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 get the best quality CT scans using the lowest possible radiation dose.
Objective:
- To determine how to improve CT scanning.
Eligibility:
- Adults 45 years of age and older who have not had a CT scan in the past year and do not have kidney disease.
Design:
- Participants will be screened with a medical history and blood and urine tests.
- Nurses will put an intravenous (IV) line into an arm or hand vein. It will stay in for several hours during the magnetic resonance imaging (MRI) and CT scans. Through this IV, blood will be taken, dye will be injected, and medicine will be given.
- Participants may have a CT scan of the heart, head, chest, abdomen, and/or pelvis. Participants will lie on their back on a table. The table will slide into a donut-shaped machine. An X-ray tube will move around the body, taking pictures.
- Participants may be given a drug called a beta blocker by mouth or through the IV tube.
- Participants heart rate and blood pressure will be monitored.
- Participants may have an MRI scan. The MRI is a large hollow tube. The participant will lie on a table that will be moved into the tube, which contains a magnetic field. When the imaging starts, a thumping sound will be heard. Headphones or earplugs will be provided to muffle the sound.
- Participants will give blood samples.
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 will be used to evaluate the performance of new imaging methods and equipment, and to provide essential ground work for research and development for use in future patient CT studies. CT imaging is a noninvasive technology. As appropriate, MRI scans will be used to compare to CT imaging findings to help validate the CT methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- ---eGFR greater than or equal to 60 mL/min/1.73m(2) within 7 days prior to scanning
- Willing to travel to the NIH for follow-up visits.
- Greater than or equal to 45 years old
Key exclusion criteria (19 listed)
- 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
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
To enhance imaging quality and safety
Time frame: ongoing
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Background: PubMed 22551595Halliburton S, Arbab-Zadeh A, Dey D, Einstein AJ, Gentry R, George RT, Gerber T, Mahesh M, Weigold WG. State-of-the-art in CT hardware and scan modes for cardiovascular CT. J Cardiovasc Comput Tomogr. 2012 May-Jun;6(3):154-63. doi: 10.1016/j.jcct.2012.04.005. Epub 2012 Apr 7.
- Background: PubMed 24589403Trattner S, Pearson GDN, Chin C, Cody DD, Gupta R, Hess CP, Kalra MK, Kofler JM Jr, Krishnam MS, Einstein AJ. Standardization and optimization of CT protocols to achieve low dose. J Am Coll Radiol. 2014 Mar;11(3):271-278. doi: 10.1016/j.jacr.2013.10.016.
- Background: PubMed 23988585Mahesh M. Variability in CT protocols. J Am Coll Radiol. 2013 Oct;10(10):805-6. doi: 10.1016/j.jacr.2013.07.005. Epub 2013 Aug 26. No abstract available.
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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.
David A Bluemke, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by National Institutes of Health Clinical Center (CC) at 1 site 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 11 inclusion and 19 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 4 Dec 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 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. 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?
To enhance imaging quality and safety (time frame: ongoing). 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 NCT02242448, which also lists 3 linked publications.
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 4 Dec 2019.