ThromboembolismPhase 1NCT02864810
Safety, Pharmacokinetics, Biodistribution, and Diagnostic Performance of [18F]GP1 PET in Thromboembolism
A Phase 1 study testing [18F]GP1 in people with Thromboembolism, run by Asan Foundation at 1 site in South Korea.
Trial summary
[18F]GP1 targets platelet GPIIb/IIIa receptor in thrombus. [18F]GP1 PET/CT imaging will noninvasively assess thrombus in whole body with good sensitivity with information of thrombus. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Thromboembolism
- 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
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Aug 2016to 9 Sep 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is ≥ 19 years of age and male or female of any race/ethnicity.
- Patient has signs or symptoms of acute DVT of the leg, acute PE or ATE; or had arterial intervention or surgery, such as endovascular abdominal aortic aneurysm repair preferably within 14 days prior to the planned study with [18F]GP1.
- Patient has thromboembolic focus/foci confirmed by standard imaging modalities within 5 days prior to administration of [18F]GP1.
- Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at time of screening.
- Patient has clinical laboratory tests that are within the following ranges, determined within 7 days prior to administration of [18F]GP1:
- White blood cell count ≥ 3.0 x 109/L;
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- Platelets ≥ 75.0 x 109/L;
- ALT and AST ≤ 3.0 times upper limit of normal;
- Bilirubin ≤ 1.5 times upper limit of normal; and
- Serum creatinine ≤ 1.5 times upper limit of normal
Who cannot join
- A patient will be excluded from this study if the patient does not fulfill the inclusion criteria, or if any of the following conditions are observed:
- Patient or patient's legally acceptable representative does not provide written informed consent.
- In case of acute DVT or PE, patient has a previous history of objectively diagnosed DVT or PE.
- Patient had pretreatment with glycoprotein IIb/IIIa inhibitors within 15 days before the administration of [18F]GP1
- Chemotherapy is scheduled to given to patient before or within 24 hours after administration of [18F]GP1.
- Female patient is pregnant or nursing.
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- Patient has concurrent severe and/or uncontrolled and/or unstable medical disease other than cancer (e.g. congestive heart failure, acute myocardial infarction, severe pulmonary disease, chronic renal or hepatic disease which could compromise participation in the study) in the judgment of the investigator.
- Patient is a relative of the investigator, student of the investigator or otherwise dependent.
- Patient has been involved in another investigative clinical study involving administration of an investigational drug from preceding 4 weeks before to 24 hours after administration of [18F]GP1.
- Patient has been previously included in this study.
- Patient has any other condition or personal circumstances that, in the judgment of the investigator, might make collection of complete data difficult or impossible.
- Additive-related precautions: This investigational product contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Non-randomized, Single Center Study to Assess Safety, Pharmacokinetics, Biodistribution, Internal Radiation Dosimetry and Diagnostic Performance of [18F]GP1 Positron Emission Tomography in Subjects With Venous or Arterial Thromboembolism
[18F]GP1 targets platelet GPIIb/IIIa receptor in thrombus. [18F]GP1 PET/CT imaging will noninvasively assess thrombus in whole body with good sensitivity with information of thrombus. Safety, pharmacokinetics, biodistribution, internal radiation dosimetry and diagnostic performance of [18F]GP1 will be assessed in all subjects.
- Conditions
- Thromboembolism
- Being tested
- [18F]GP1
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]GP1Drug
Also called GP1
[18F]GP1 PET/CT imaging for detecting thromboembolism
| Study group | Role | What they receive |
|---|---|---|
| [18F]GP1 PET/CT imaging | Experimental | Maximally 10 patients with deep vein thrombosis, pulmonary embolism, or arterial thromboembolism, respectively will be enrolled in the study (plus replacements for drop-outs).
Intravenous injection and PET/CT 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.
Detection rate of thromboembolic focus/foci with [18F]GP1 PET/CT
Measured: 6 months
Secondary outcomes (9)
Quantitative assessment of [18F]GP1 uptake in thromboembolic focus/foci as measured by standardized uptake value (SUV)
Measured: 6 months
Biodistribution and radiation dosimetry of [18F]GP1 as measured by SUV
Measured: 6 months
Biodistribution and radiation dosimetry of [18F]GP1 as measured by radiation doses per organ (μGy/MBq).
Measured: 6 months
Pharmacokinetics of [18F]GP1 as measured by area under the curve
Measured: 6 months
Pharmacokinetics of [18F]GP1 as measured by Cmax
Measured: 6 months
Pharmacokinetics of [18F]GP1 as measured by Tmax
Measured: 6 months
Pharmacokinetics of [18F]GP1 as measured by percent fraction
Measured: 6 months
Safety of [18F]GP1 as measured by the number of participants with adverse events and significant changes in vital signs, electrocardiogram, physical examination and laboratory data that are related to treatment.
Evaluation of safety of [18F]GP1
Measured: 6 months
Correlation of [18F]GP1 activity with fibrinogen and platelet glycoprotein IIb/IIIa and P-selectin expression.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study start4 Aug 2016
- Primary completion9 Sep 2017
- Study completion9 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThromboembolismStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864810
- Sponsor's protocol ID
- GP1-1501
- Status last verified
- May 2018
- First submitted
- 3 Aug 2016
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chae SY, Kwon TW, Jin S, Kwon SU, Sung C, Oh SJ, Lee SJ, Oh JS, Han Y, Cho YP, Lee N, Kim JY, Koglin N, Berndt M, Stephens AW, Moon DH. A phase 1, first-in-human study of 18F-GP1 positron emission tomography for imaging acute arterial thrombosis. EJNMMI Res. 2019 Jan 7;9(1):3. doi: 10.1186/s13550-018-0471-8.
PubMed 30617563
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Non-randomized, Single Center Study to Assess Safety, Pharmacokinetics, Biodistribution, Internal Radiation Dosimetry and Diagnostic Performance of [18F]GP1 Positron Emission Tomography in Subjects With Venous or Arterial Thromboembolism
- ClinicalTrials.gov ID
- NCT02864810
- Acronym / sponsor ID
- GP1-1501
- Conditions
- Thromboembolism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Asan FoundationUniversity, hospital or other
- Study start
- 4 Aug 2016 (actual)
- Primary completion
- 9 Sep 2017 (actual)
- Study completion
- 9 Sep 2017 (actual)
- First posted
- 12 Aug 2016 (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.
[18F]GP1 targets platelet GPIIb/IIIa receptor in thrombus. [18F]GP1 PET/CT imaging will noninvasively assess thrombus in whole body with good sensitivity with information of thrombus. Safety, pharmacokinetics, biodistribution, internal radiation dosimetry and diagnostic performance of [18F]GP1 will be assessed in all subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]GP1 PET/CT imaging | Experimental | Drug: [18F]GP1Maximally 10 patients with deep vein thrombosis, pulmonary embolism, or arterial thromboembolism, respectively will be enrolled in the study (plus replacements for drop-outs). Intravenous injection and PET/CT scanning of [18F]GP1 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient is ≥ 19 years of age and male or female of any race/ethnicity.
- Patient has signs or symptoms of acute DVT of the leg, acute PE or ATE; or had arterial intervention or surgery, such as endovascular abdominal aortic aneurysm repair preferably within 14 days prior to the planned study with [18F]GP1.
- Patient has thromboembolic focus/foci confirmed by standard imaging modalities within 5 days prior to administration of [18F]GP1.
- Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at time of screening.
- Patient has clinical laboratory tests that are within the following ranges, determined within 7 days prior to administration of [18F]GP1:
Key exclusion criteria (12 listed)
- A patient will be excluded from this study if the patient does not fulfill the inclusion criteria, or if any of the following conditions are observed:
- Patient or patient's legally acceptable representative does not provide written informed consent.
- In case of acute DVT or PE, patient has a previous history of objectively diagnosed DVT or PE.
- Patient had pretreatment with glycoprotein IIb/IIIa inhibitors within 15 days before the administration of [18F]GP1
- Chemotherapy is scheduled to given to patient before or within 24 hours after administration of [18F]GP1.
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: GP1[18F]GP1 PET/CT imaging for detecting thromboembolism | Drug | [18F]GP1 PET/CT imaging |
Primary outcome
Detection rate of thromboembolic focus/foci with [18F]GP1 PET/CT
Time frame: 6 months
9 secondary outcomes
Quantitative assessment of [18F]GP1 uptake in thromboembolic focus/foci as measured by standardized uptake value (SUV)
Time frame: 6 months
Biodistribution and radiation dosimetry of [18F]GP1 as measured by SUV
Time frame: 6 months
Biodistribution and radiation dosimetry of [18F]GP1 as measured by radiation doses per organ (μGy/MBq).
Time frame: 6 months
Pharmacokinetics of [18F]GP1 as measured by area under the curve
Time frame: 6 months
Pharmacokinetics of [18F]GP1 as measured by Cmax
Time frame: 6 months
Pharmacokinetics of [18F]GP1 as measured by Tmax
Time frame: 6 months
Pharmacokinetics of [18F]GP1 as measured by percent fraction
Time frame: 6 months
Safety of [18F]GP1 as measured by the number of participants with adverse events and significant changes in vital signs, electrocardiogram, physical examination and laboratory data that are related to treatment.
Time frame: 6 months
Correlation of [18F]GP1 activity with fibrinogen and platelet glycoprotein IIb/IIIa and P-selectin expression.
Time frame: 6 months
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 18 May 2018.
- Derived from this study: PubMed 30617563Chae SY, Kwon TW, Jin S, Kwon SU, Sung C, Oh SJ, Lee SJ, Oh JS, Han Y, Cho YP, Lee N, Kim JY, Koglin N, Berndt M, Stephens AW, Moon DH. A phase 1, first-in-human study of 18F-GP1 positron emission tomography for imaging acute arterial thrombosis. EJNMMI Res. 2019 Jan 7;9(1):3. doi: 10.1186/s13550-018-0471-8.
- Individual participant dataSharing planned: No
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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.
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 Thromboembolism, run by Asan Foundation at 1 site 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 10 inclusion and 12 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 18 May 2018. 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 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. 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?
Detection rate of thromboembolic focus/foci with [18F]GP1 PET/CT (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02864810, which also lists 1 linked publication.
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 18 May 2018.