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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00972946 |
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Date of registration:
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07/09/2009 |
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Primary sponsor: |
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Public title:
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Cell Tracking Using Superparamagnetic Particles of Iron Oxide (SPIO) and Magnetic Resonance Imaging (MRI) - A Pilot Study
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Scientific title:
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The Use of Magnetic Resonance Imaging and Superparamagnetic Particles of Iron Oxide in Cardiovascular Disease - a Pilot Study in Healthy Volunteers |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00972946 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Jennifer MJ Richards, MBChB BSc MRCS |
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Address:
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Telephone:
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0131 242 3621 |
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Email:
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jenny.richards@ed.ac.uk |
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Affiliation:
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Name:
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David E Newby |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Edinburgh |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy volunteers
- Age >18 years
Exclusion Criteria:
- Pregnancy
- Contraindication to MRI scanning (detected by safety questionnaire) including severe
claustrophobia
- Inability or refusal to give informed consent
- Renal or hepatic dysfunction
- HIV/hepatitis B/ hepatitis C/ HTLV/ syphilis
- Intercurrent illness
- Blood dyscrasias
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy Volunteer
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Intervention(s)
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Biological: Administration of autologous Endorem-labelled mononuclear cells intravenously
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Drug: Administration of Endorem
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Primary Outcome(s)
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Change in signal intensity in the region of interest on MRI scanning
[Time Frame: 0 hours, 24 hours, 48 hours, 5-7 days]
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Secondary ID(s)
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2007/R/CAR/15.2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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