Abdominal Aortic AneurysmPhase 1PET-GP1_1NCT02469376
Evaluation of a New Imagingtechnologie for Thrombosis
A Phase 1 study testing [18F]-GP1 in people with Abdominal Aortic Aneurysm and Deep Vein Thrombosis, run by University of Zurich at 1 site in Switzerland.
Trial summary
Arterial and venous thrombi play an important role in various vascular diseases such as myocardial infarction, stroke, transient ischemic attacks (TIA) and pulmonary embolism. These thromboembolic disorders are the leading causes of morbidity and mortality worldwide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Deep Vein Thrombosis
- What is being tested?
- [18F]-GP1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2014to 1 Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with AAA (diameter >3.5cm in duplex sonography) or acute DVT.
- Male and female patients 18 years and older,
- Signed Informed Consent after being informed
Who cannot join
- contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
- women who are pregnant or breast feeding,
- women with the intention to become pregnant during the course of the study,
- other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease),
- renal clearance < 30 mL/min
- known or suspected non-compliance, drug or alcohol abuse,
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- inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the subject,
- participation in another study with an investigational drug during the present study and 7 days thereafter.
- enrolment of the investigator, his family members, employees and other dependent persons
- last systemic treatment with GP IIb/IIIa antagonists should not have been applied within 48 h before performing study exam
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Nuclear Medicine
Zurich, Canton of Zurich, 8091
About this study
Official title: Biodistribution, Imaging Properties, and Radiation Dosimetry of [18F]-GP1 Positron Emission Tomography (PET) Tracer in Vascular Disease Imaging
Arterial and venous thrombi play an important role in various vascular diseases such as myocardial infarction, stroke, transient ischemic attacks (TIA) and pulmonary embolism. These thromboembolic disorders are the leading causes of morbidity and mortality worldwide. A non-invasive method for the quantitative and effective detection of thrombi in the whole body has not yet been established. In spite of the available techniques, 30% to 40% of ischemic strokes "cryptogenic" (undetermined cause, the source of thromboembolism is never identified). Possible causes of cryptogenic stroke atherosclerosis include in the aortic arch or intracranial arteries. A plaque in the arch or other large vessels could be an important source of cryptogenic strokes, however, are those difficult to detect by routine methods. The approach of thrombus targeted molecular imaging could identify potentially troublesome plaques early on before they become a dangerous rupture. The hypothesis is that the radiotracer 18F-arterial GP1 and venous thrombi using positron emission tomography (PET) can be made visible. The primary goal is the potential applicability of the substance as a PET tracer for diagnosing thrombi.
Read the detailed description
This is a first in man study with which we are testing the feasibility of the use of this radiopharmaceutical product to visualize a thrombus.
- Conditions
- Abdominal Aortic Aneurysm, Deep Vein Thrombosis
- Being tested
- [18F]-GP1
- Medical subject headings
- Aortic Aneurysm, Abdominal, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-GP1Drug
Also called GP1
Radiopharmaceutical Product (Tracer) to visualize with Positron Emission Tomography a thrombus in humans.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosis with GP1 | Experimental | Injection and scanning of [18F]-GP1 Receives: Drug: [18F]-GP1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of biodistribution of [18F]-GP1 and its properties as a PET imaging agent for detection of abdominal aortic aneurysm (AAA) and deep vein thrombosis (DVT).
Biodistribution and diagnostic properties of the new Tracer
Measured: 12 Months
Secondary outcomes (1)
Calculation of the effective dose to the patient according to the tissue distribution data of [18F]-GP1 (Dosimetry)
Dosimtery assessment of the new Tracer
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startSep 2014
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Lantheus Biosciences Ltd.
- Responsible party
- Sponsor
- Investigators
- Philipp A Kaufmann, Prof, Principal investigator, University Hospital Zurich, Department of Nuclear Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469376
- Sponsor's protocol ID
- PET - GP1_1
- Acronym
- PET-GP1_1
- Status last verified
- May 2017
- First submitted
- 8 Jun 2015
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biodistribution, Imaging Properties, and Radiation Dosimetry of [18F]-GP1 Positron Emission Tomography (PET) Tracer in Vascular Disease Imaging
- ClinicalTrials.gov ID
- NCT02469376
- Acronym / sponsor ID
- PET-GP1_1 / PET - GP1_1
- Conditions
- Abdominal Aortic Aneurysm, Deep Vein Thrombosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Lantheus Biosciences Ltd.
- Study start
- Sep 2014
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 11 Jun 2015 (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.
Arterial and venous thrombi play an important role in various vascular diseases such as myocardial infarction, stroke, transient ischemic attacks (TIA) and pulmonary embolism. These thromboembolic disorders are the leading causes of morbidity and mortality worldwide. A non-invasive method for the quantitative and effective detection of thrombi in the whole body has not yet been established. In spite of the available techniques, 30% to 40% of ischemic strokes "cryptogenic" (undetermined cause, the source of thromboembolism is never identified). Possible causes of cryptogenic stroke atherosclerosis include in the aortic arch or intracranial arteries. A plaque in the arch or other large vessels could be an important source of cryptogenic strokes, however, are those difficult to detect by routine methods. The approach of thrombus targeted molecular imaging could identify potentially troublesome plaques early on before they become a dangerous rupture. The hypothesis is that the radiotracer 18F-arterial GP1 and venous thrombi using positron emission tomography (PET) can be made visible. The primary goal is the potential applicability of the substance as a PET tracer for diagnosing thrombi.
Detailed description
This is a first in man study with which we are testing the feasibility of the use of this radiopharmaceutical product to visualize a thrombus.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosis with GP1 | Experimental | Drug: [18F]-GP1Injection and scanning of [18F]-GP1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with AAA (diameter >3.5cm in duplex sonography) or acute DVT.
- Male and female patients 18 years and older,
- Signed Informed Consent after being informed
Key exclusion criteria (10 listed)
- contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
- women who are pregnant or breast feeding,
- women with the intention to become pregnant during the course of the study,
- other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease),
- renal clearance < 30 mL/min
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]-GP1Also: GP1Radiopharmaceutical Product (Tracer) to visualize with Positron Emission Tomography a thrombus in humans. | Drug | Diagnosis with GP1 |
Primary outcome
Assessment of biodistribution of [18F]-GP1 and its properties as a PET imaging agent for detection of abdominal aortic aneurysm (AAA) and deep vein thrombosis (DVT).
Time frame: 12 Months
Biodistribution and diagnostic properties of the new Tracer
1 secondary outcome
Calculation of the effective dose to the patient according to the tissue distribution data of [18F]-GP1 (Dosimetry)
Time frame: 12 Months
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
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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.
Philipp A Kaufmann, Prof principal investigator
University Hospital Zurich, Department of Nuclear Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F]-GP1 in people with Abdominal Aortic Aneurysm and Deep Vein Thrombosis, run by University of Zurich at 1 site in Switzerland.
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 10 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 9 May 2017. 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 Switzerland. 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 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 was stopped early (reason given: Slow recruitment). 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?
Assessment of biodistribution of [18F]-GP1 and its properties as a PET imaging agent for detection of abdominal aortic aneurysm (AAA) and deep vein thrombosis (DVT). (time frame: 12 Months). 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 9 May 2017.