CancerNCT00416065
PET/CT to Identify "Vulnerable" Arterial Plaque
A study testing PET/CT imaging in people with Cancer, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The purpose of this research is to evaluate the presence, location and intensity of FDG uptake in the large arteries using the new technology of fused PET/CT imaging and to compare FDG uptake with the presence of arterial calcifications as seen on the simultaneously acquired CT, in order to determine if FDG was… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- PET/CT imaging
- Type of treatment
- Medical device
- How many people
- 800 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2004to not given
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for clinical FDG-PET/CT studies
- Patients 50 yr or older
- Patients signed informed consent
Who cannot join
- Patients unable or unwilling to tolerate the scan until its completion
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Medical Center
Haifa
Ora Israel, MD, 972-4-8543009, o_israel@rambam.health.gov.il
About this study
The purpose of this research is to evaluate the presence, location and intensity of FDG uptake in the large arteries using the new technology of fused PET/CT imaging and to compare FDG uptake with the presence of arterial calcifications as seen on the simultaneously acquired CT, in order to determine if FDG was increases incalcified plaque or in a different location in the arterial wall. we will also evaluate the relationship between FDG localization and future cardiovascular events in out patient population
- Conditions
- Cancer
- Being tested
- PET/CT imaging
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT imagingDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
the impact of the imaging modality on patient management
Secondary outcomes (1)
the impact of the imaging modality on patient management
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2006 (estimated)
- Study startApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Ora Israel, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416065
- Sponsor's protocol ID
- plaqueCTIL
- Status last verified
- Nov 2006
- First submitted
- 26 Dec 2006
- Last updated
- 27 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/CT to Identify "Vulnerable" Arterial Plaque
- ClinicalTrials.gov ID
- NCT00416065
- Acronym / sponsor ID
- plaqueCTIL
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Apr 2004
- First posted
- 27 Dec 2006 (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.
The purpose of this research is to evaluate the presence, location and intensity of FDG uptake in the large arteries using the new technology of fused PET/CT imaging and to compare FDG uptake with the presence of arterial calcifications as seen on the simultaneously acquired CT, in order to determine if FDG was increases incalcified plaque or in a different location in the arterial wall. we will also evaluate the relationship between FDG localization and future cardiovascular events in out patient population
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients referred for clinical FDG-PET/CT studies
- Patients 50 yr or older
- Patients signed informed consent
Key exclusion criteria (1 listed)
- Patients unable or unwilling to tolerate the scan until its completion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CT imaging | Device | – |
Primary outcome
the impact of the imaging modality on patient management
1 secondary outcome
the impact of the imaging modality on patient management
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2006.
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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.
Ora Israel, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/CT imaging in people with Cancer, run by Rambam Health Care Campus at 1 site in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 27 Dec 2006. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ora Israel, MD (972-4-8543009, o_israel@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the impact of the imaging modality on patient management. 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 27 Dec 2006.