AtherosclerosisPhase 1NCT01893489
Visualization of Carotid Atherosclerosis by 68Ga-MSA
A Phase 1 study testing 68Gallium-MSA in people with Atherosclerosis and Carotid Atherosclerosis, run by Korea University at 2 sites in South Korea.
Trial summary
Until now, no specific atherosclerosis-targeting agent labeled with positron emitter is not yet available. Investigators developed neomannosyl human serum albumin(MSA) for the terminal mannose residues of MSA binding with the mannose receptors of macrophages in atherosclerosis, and investigators investigate whether… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Carotid Atherosclerosis, Noninvasive Imaging of Atherosclerosis
- What is being tested?
- 68Gallium-MSA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Sep 2012to Aug 2013
- Phase
- Phase 1
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- •coronary artery disease patients with carotid plaques
- control without carotid plaque
Who cannot join
- •pregnancy, allergy to albumin, any acute or chronic inflammatory disease, hematologic disease, liver disease, renal disease
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Department of Nuclear Medicine, Institute of Radiation Medicine,
Seoul, 110-744
Korea University Guro Hospital
Seoul, 152-703
About this study
Official title: Phase I Study to Evaluated the Safety of Noninvasive Molecular Imaging for the Detection of Inflammation in Carotid Atherosclerotic Lesions by Using Ga-68-NOTA-MSA in Healthy Volunteers and Patients With Coronary Artery Disease
Until now, no specific atherosclerosis-targeting agent labeled with positron emitter is not yet available. Investigators developed neomannosyl human serum albumin(MSA) for the terminal mannose residues of MSA binding with the mannose receptors of macrophages in atherosclerosis, and investigators investigate whether 68Ga-MSA can be a novel agent for non-invasive molecular imaging of carotid atherosclerotic lesion in PET.
- Being tested
- 68Gallium-MSA
- Keywords
- positron emission tomography, macrophage, neomannosyl human serum albumin
- Medical subject headings
- Atherosclerosis, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Gallium-MSAOther
68Gallium-MSA 2.0 mci for Positron Emission Tomogram(PET) imaging
| Study group | Role | What they receive |
|---|---|---|
| Atherosclerosis | Active comparator | coronary artery disease patients with carotid plaques confirmed by a ultrasound study Receives: Other: 68Gallium-MSA |
| control | Sham comparator | no coronary artery disease patients without carotid plaques confirmed by a ultrasound study Receives: Other: 68Gallium-MSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
side reactions at MSA injection site of the skin
development of unexpected skin rashes or other skin lesions at MSA injection site of the skin with 2 hours after MSA injection
Measured: with 2 hours after MSA injection
unstable changes of vital signs and development of abnormal biochemical parameters
This includes unstable changes of vital signs including blood pressure, body temperature and heart rate, and abnormal changes of biochemical parameters such as hematologic, hepatic and renal functions.
Measured: 24 hours after MSA injection
Secondary outcomes (2)
standard uptake unit(SUV) at carotid arteries
Measured: baseline
SUV at aorta and iliac arteries
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Collaborators
- SHIN JIN MEDICS
- Responsible party
- Principal investigator, Hong Seog Seo, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893489
- Sponsor's protocol ID
- Ga_MSA_CAD_carotid
- Status last verified
- Aug 2013
- First submitted
- 27 Jun 2013
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Evaluated the Safety of Noninvasive Molecular Imaging for the Detection of Inflammation in Carotid Atherosclerotic Lesions by Using Ga-68-NOTA-MSA in Healthy Volunteers and Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01893489
- Acronym / sponsor ID
- Ga_MSA_CAD_carotid
- Keywords
- positron emission tomography, macrophage, neomannosyl human serum albumin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Collaborators
- SHIN JIN MEDICS
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 9 Jul 2013 (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.
Until now, no specific atherosclerosis-targeting agent labeled with positron emitter is not yet available. Investigators developed neomannosyl human serum albumin(MSA) for the terminal mannose residues of MSA binding with the mannose receptors of macrophages in atherosclerosis, and investigators investigate whether 68Ga-MSA can be a novel agent for non-invasive molecular imaging of carotid atherosclerotic lesion in PET.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atherosclerosis | Active comparator | Other: 68Gallium-MSAcoronary artery disease patients with carotid plaques confirmed by a ultrasound study |
| control | Sham comparator | Other: 68Gallium-MSAno coronary artery disease patients without carotid plaques confirmed by a ultrasound study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- •coronary artery disease patients with carotid plaques
Key exclusion criteria (1 listed)
- •pregnancy, allergy to albumin, any acute or chronic inflammatory disease, hematologic disease, liver disease, renal disease
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 |
|---|---|---|
| 68Gallium-MSA68Gallium-MSA 2.0 mci for Positron Emission Tomogram(PET) imaging | Other | Atherosclerosis, control |
Primary outcome
side reactions at MSA injection site of the skin
Time frame: with 2 hours after MSA injection
development of unexpected skin rashes or other skin lesions at MSA injection site of the skin with 2 hours after MSA injection
unstable changes of vital signs and development of abnormal biochemical parameters
Time frame: 24 hours after MSA injection
This includes unstable changes of vital signs including blood pressure, body temperature and heart rate, and abnormal changes of biochemical parameters such as hematologic, hepatic and renal functions.
2 secondary outcomes
standard uptake unit(SUV) at carotid arteries
Time frame: baseline
SUV at aorta and iliac arteries
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 68Gallium-MSA in people with Atherosclerosis and Carotid Atherosclerosis, run by Korea University at 2 sites in South Korea.
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 2 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: finished, as of the sponsor's last update on 27 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
side reactions at MSA injection site of the skin (time frame: with 2 hours after MSA injection). The study lists 2 primary outcomes in all. 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 Aug 2013.