AtherosclerosisPhase 2/3NCT03291093
18F-Flutemetamol and Plaque Vulnerability
A Phase 2/3 study testing 18F-Flutemetamol PET/MRI in people with Atherosclerosis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Amyloid beta (Ab) is mainly known for its role in Alzheimer's disease (AD) pathology. However, Ab seems not only to be involved in AD pathology, but also in atherosclerosis, which might explain the remarkable similarities in risk factors between these two pathologies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- 18F-Flutemetamol PET/MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Feb 2018to 31 Dec 2019
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- All patients:
- Severe cognitive impairment, neurological deficit or comorbidity causing the study to be too high a burden for the patient or disrupting patient's co- operation with scan procedures
- Evident other causality for stroke (cardiac embolus, small vessel disease or thrombogenic diathesis)
- Pregnant women and nursing mothers
- Contra-indications for MRI (49):
- Ferromagnetic implants, such as pacemakers and other electronic implants
Show all 21Show fewer
- Ferromagnetic (intracerebral) vascular clips
- Metallic cochlear implants
- Metallic splinters in eye(s) or other magnetic metallic foreign bodies elsewhere
- Claustrophobia
- Relative contra-indications for MRI-contrast agents (50):
- GFR <30ml/min/1,73m2
- Previous allergic reaction to MRI contrast agent
- Contra-indication 18F-Flutemetamol:
- Known allergic reaction to flutemetamol or polysorbate 80 or any of the excipients.
- Severe liver dysfunction.
- Patients undergoing CEA:
- Comorbidity associated with high operative risk
- Occlusion of the internal carotid artery on the symptomatic side
- Near occlusion on the symptomatic side
- Complete infarction of the symptomatic anterior circulation/severe neurological deficit
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Centre (MUMC+)
Maastricht, Limburg, 6229 HX
Ellen Boswijk, MD, +31433876549, ellen.boswijk@mumc.nl
About this study
Official title: Identification of Plaque Vulnerability Wit PET/MRI: a Feasibility Study of 18F-Flutemetamol in Atherosclerosis
Rationale: Amyloid beta (Ab) is mainly known for its role in Alzheimer's disease (AD) pathology. However, Ab seems not only to be involved in AD pathology, but also in atherosclerosis, which might explain the remarkable similarities in risk factors between these two pathologies. In vitro studies suggest that a major part of this association is based on the ability of amyloid to lead to macrophage activation and thus inflammation. These data lead to the hypothesis that Ab is associated with plaque vulnerability.
18F-Flutemetamol is a PET tracer with high affinity for Ab. This has been extensively studied in AD patients.
Read more
Objective: To validate 18F-Flutemetamol PET in the evaluation of plaque vulnerability.
Study design: A cross-sectional validation study. Study population: 25 adults, who have recently (<14days) experienced a transient ischemic attack (TIA) or stroke with a carotid artery plaque of ≥30% and without evidence of another etiology than carotid atherosclerosis (i.e. cardiac or small vessel).
Of these 25 patients, 10 patients will be included who have been scheduled for carotid endarterectomy (CEA). The other 15 will be selected of patients who are not scheduled to undergo CEA.
Intervention: All patients will undergo a PET/MRI scan with 18F-Flutemetamol, either before the scheduled CEA or within the first 30 days following the cerebrovascular event. Imaging will include the carotid and coronary arteries as well as the brain.
Main study parameters/endpoints: Tracer uptake in the carotid artery will be correlated to vulnerable plaque characteristics as assessed by MRI. In the 10 CEA patients, tracer uptake and MR imaging of different plaque characteristics will be validated with plaque histology of the surgically removed specimen.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no additional benefit for study subjects. Study subjects will receive the same treatment as non-participating patients. Patients will be screened for in- and exclusion criteria to minimize risks.
For optimal MR imaging patients will be injected with a Gadolinium based contrast agent, which is a common procedure and associated with very low risk of complications. The PET tracer 18F-flutemetamol has been studied extensively and is currently used in patients with AD. Adverse events were not frequent and mainly mild. The radioactivity dose will be around 6.8 mSv.
- Conditions
- Atherosclerosis
- Being tested
- 18F-Flutemetamol PET/MRI
- Keywords
- PET/MRI, Amyloid, Flutemetamol
- Medical subject headings
- Atherosclerosis, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-Flutemetamol PET/MRIDrug
All patients will undergo a PET/MRI of the carotids after 18F-Flutemetamol injection.
| Study group | Role | What they receive |
|---|---|---|
| 18F-Flutemetamol PET/MRI dynamic | Experimental | All included patients will be patients with a recent stroke and a significant carotid plaque.
The first 5 patients will undergo a slightly longer scan protocol to determine optimal scan time for the use of 18F-Flutemetamol in atherosclerosis imaging. Receives: Drug: 18F-Flutemetamol PET/MRI |
| 18F-Flutemetamol PET/MRI CEA | Experimental | 10 patients will be selected from patients that will undergo carotid endarterectomy (CEA) and will undergo the the optimized (shorter) scan protocol with 18F-Flutemetamol. The decision for this operation is made by the surgeon and neurologist and based on clinical standards and is thus independent of study participation. Receives: Drug: 18F-Flutemetamol PET/MRI |
| 18F-Flutemetamol PET/MRI | Experimental | The remaining 10 patients will undergo the optimized (shorter) scan protocol with 18F-Flutemetamol. Receives: Drug: 18F-Flutemetamol PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-Flutemetamol uptake carotids
measured as SUV and TBR
Measured: 0-120min
Secondary outcomes (5)
18F-Flutemetamol uptake coronaries
measured as SUV and TBR
Measured: 0-150min
18F-Flutemetamol uptake in the brain
measured as SUVR
Measured: 0-150min
CEA - plaque inflammation
macrophage content
Measured: 1-14 dys
MRI plaque characteristics carotid
semi quantitive analysis
Measured: 0-150min
CEA - plaque amyloid burden
Immunohistochemistry
Measured: 1-14 dys
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start1 Feb 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
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.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291093
- Sponsor's protocol ID
- NL58543.068.16
- Status last verified
- Jan 2019
- First submitted
- 19 Sep 2017
- Last updated
- 11 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Plaque Vulnerability Wit PET/MRI: a Feasibility Study of 18F-Flutemetamol in Atherosclerosis
- ClinicalTrials.gov ID
- NCT03291093
- Acronym / sponsor ID
- NL58543.068.16
- Conditions
- Atherosclerosis
- Keywords
- PET/MRI, Amyloid, Flutemetamol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 25 Sep 2017 (actual)
- 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.
Rationale: Amyloid beta (Ab) is mainly known for its role in Alzheimer's disease (AD) pathology. However, Ab seems not only to be involved in AD pathology, but also in atherosclerosis, which might explain the remarkable similarities in risk factors between these two pathologies. In vitro studies suggest that a major part of this association is based on the ability of amyloid to lead to macrophage activation and thus inflammation. These data lead to the hypothesis that Ab is associated with plaque vulnerability.
18F-Flutemetamol is a PET tracer with high affinity for Ab. This has been extensively studied in AD patients.
Objective: To validate 18F-Flutemetamol PET in the evaluation of plaque vulnerability.
Study design: A cross-sectional validation study. Study population: 25 adults, who have recently (<14days) experienced a transient ischemic attack (TIA) or stroke with a carotid artery plaque of ≥30% and without evidence of another etiology than carotid atherosclerosis (i.e. cardiac or small vessel).
Of these 25 patients, 10 patients will be included who have been scheduled for carotid endarterectomy (CEA). The other 15 will be selected of patients who are not scheduled to undergo CEA.
Intervention: All patients will undergo a PET/MRI scan with 18F-Flutemetamol, either before the scheduled CEA or within the first 30 days following the cerebrovascular event. Imaging will include the carotid and coronary arteries as well as the brain.
Main study parameters/endpoints: Tracer uptake in the carotid artery will be correlated to vulnerable plaque characteristics as assessed by MRI. In the 10 CEA patients, tracer uptake and MR imaging of different plaque characteristics will be validated with plaque histology of the surgically removed specimen.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no additional benefit for study subjects. Study subjects will receive the same treatment as non-participating patients. Patients will be screened for in- and exclusion criteria to minimize risks.
For optimal MR imaging patients will be injected with a Gadolinium based contrast agent, which is a common procedure and associated with very low risk of complications. The PET tracer 18F-flutemetamol has been studied extensively and is currently used in patients with AD. Adverse events were not frequent and mainly mild. The radioactivity dose will be around 6.8 mSv.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 18F-Flutemetamol PET/MRI dynamic | Experimental | Drug: 18F-Flutemetamol PET/MRIAll included patients will be patients with a recent stroke and a significant carotid plaque. The first 5 patients will undergo a slightly longer scan protocol to determine optimal scan time for the use of 18F-Flutemetamol in atherosclerosis imaging. |
| 18F-Flutemetamol PET/MRI CEA | Experimental | Drug: 18F-Flutemetamol PET/MRI10 patients will be selected from patients that will undergo carotid endarterectomy (CEA) and will undergo the the optimized (shorter) scan protocol with 18F-Flutemetamol. The decision for this operation is made by the surgeon and neurologist and based on clinical standards and is thus independent of study participation. |
| 18F-Flutemetamol PET/MRI | Experimental | Drug: 18F-Flutemetamol PET/MRIThe remaining 10 patients will undergo the optimized (shorter) scan protocol with 18F-Flutemetamol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- All patients:
- Patients undergoing CEA:
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 |
|---|---|---|
| 18F-Flutemetamol PET/MRIAll patients will undergo a PET/MRI of the carotids after 18F-Flutemetamol injection. | Drug | 18F-Flutemetamol PET/MRI, 18F-Flutemetamol PET/MRI CEA, 18F-Flutemetamol PET/MRI dynamic |
Primary outcome
18F-Flutemetamol uptake carotids
Time frame: 0-120min
measured as SUV and TBR
5 secondary outcomes
18F-Flutemetamol uptake coronaries
Time frame: 0-150min
18F-Flutemetamol uptake in the brain
Time frame: 0-150min
CEA - plaque inflammation
Time frame: 1-14 dys
MRI plaque characteristics carotid
Time frame: 0-150min
CEA - plaque amyloid burden
Time frame: 1-14 dys
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
Maastricht University Medical Centre (MUMC+)
Maastricht, Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 18F-Flutemetamol PET/MRI in people with Atherosclerosis, run by Maastricht University Medical Center at 1 site in Netherlands.
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 0 inclusion and 21 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 11 Jul 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 Netherlands. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18F-Flutemetamol uptake carotids (time frame: 0-120min). 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 11 Jul 2019.