Venous ThrombosisPhase 2NCT04156230
Diagnostic Validity of [18F]GP1 PET for Diagnosing Acute Deep Vein Thrombosis
A Phase 2 study testing [18F]GP1 positron emission tomography/computed tomography in people with Venous Thrombosis, run by Dae Hyuk Moon at 1 site in South Korea.
Trial summary
The first-in-human study of [18F]GP1 positron emission tomography/computed tomography (PET/CT) showed that [18F]GP1 is safe and promising novel PET tracer for imaging acute venous thromboembolism with favorable biodistribution and pharmacokinetics in patients. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Venous Thrombosis
- What is being tested?
- [18F]GP1 positron emission tomography/computed tomography
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jan 2020to 13 Aug 2025
- Phase
- Phase 2
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject will be enrolled if he/she meets all of the following inclusion criteria.
- Subject is aged between 19 and 79 years and male or female of any race/ethnicity.
- Patient has a first episode of clinically suspected acute deep vein thrombosis of the lower extremity within 14 days prior to the planned [18F]GP1 PET/CT.
- The pretest probability for deep vein thrombosis is likely by two-level Wells score (≥ 2), or the D-dimer test is positive.
- Subject underwent or is scheduled to undergo venous ultrasonography within 7 days of [18F]GP1 PET/CT:
- Patient has Eastern Cooperative Oncology Group performance status of 0-2 at time of screening.
Who cannot join
- A subject is to be excluded from the study if he/she does not fulfill the inclusion criteria or display any of the following criteria.
- Subject or subject's legally acceptable representative does not provide written informed consent.
- Subject has a previous history of objectively diagnosed deep vein thrombosis or pulmonary embolism.
- Subject has symptoms of acute deep vein thrombosis lasting for longer than 4 weeks at time of screening.
- Subject is suspected to have pulmonary embolism with shock or hypotension
- Subject had pretreatment with glycoprotein IIb/IIIa inhibitors within 15 days before the administration of [18F]GP1.
Show all 14Show fewer
- Anticancer chemotherapy is scheduled to be given to subject before or within 24 hours after administration of [18F]GP1.
- Female subject is pregnant or nursing. Exclusion of the possibility of pregnancy is made by one of the following: 1) woman is physiologically post-menopausal (cessation of menses for more than 2 years), or 2) woman is surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy). If the woman is of childbearing potential, a urine pregnancy test performed within 24 hours immediately prior to administration of [18F]GP1 has to be negative and the women is advised to apply contraceptive measures during her participation in this study.
- Subject 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.
- Subject is a relative of the investigator, student of the investigator or otherwise dependent.
- Subject has been involved in another investigative clinical study involving administration of an investigational drug from preceding 4 weeks prior to the study enrollment or within 24 hours after administration of [18F]GP1.
- Subject has been previously included in this study.
- Subject 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 2, Open-label, Non-randomized, Single Center Study to Assess Diagnostic Validity of [18F]GP1 Positron Emission Tomography/Computed Tomography for Acute Deep Vein Thrombosis of the Lower Extremities in Symptomatic Patients
The first-in-human study of [18F]GP1 positron emission tomography/computed tomography (PET/CT) showed that [18F]GP1 is safe and promising novel PET tracer for imaging acute venous thromboembolism with favorable biodistribution and pharmacokinetics in patients. The goal of this phase 2 study is to evaluate whether [18F]GP1 PET/CT is sensitive and specific for the diagnosis of acute deep vein thrombosis in the appropriate patient population and clinical setting. This study will provide preliminary evidence of efficacy and expand the safety database in a larger group of patients who were suspected of having acute deep vein thrombosis. This study will further optimize image acquisition techniques, and develop methods and criteria by which [18F]GP1 PET/CT will be evaluated. Other critical questions about [18F]GP1 biodistribution including [18F]GP1 uptake in pulmonary and systemic arteries will be evaluated.
Read the detailed description
This study is an open label, non-randomized, single center, intervention study. An estimated 63 symptomatic subjects with a pretest score of deep vein thrombosis likely (Wells score ≥ 2) or a positive D-dimer test will receive [18F]GP1 PET/CT to evaluate the diagnostic validity of [18F]GP1 PET/CT for detecting deep vein thrombosis foci in lower extremities.
The study comprises 3 periods: screening, treatment, and follow-up. The screening period starts with the patient's signature on the informed consent form and ends with assignment to treatment that is inclusion of the subject for treatment. The treatment period starts with baseline measurements, and ends with the last measurement/procedure on the day of intravenous injection of 250 MBq of [18F]GP1. The follow-up period contains the end-of-study interview. Key measurement is the PET/CT image acquisition about 120 minutes after the single injection of [18F]GP1 This study includes venous ultrasonography of deep vein thrombosis as a valid reference standard. [18F]GP1 PET/CT will be assessed qualitatively and quantitatively by three experienced readers.
This study will be monitored regularly by a clinical research associate from the sponsor or a designated contract research organization. Data quality and study integrity will be assessed. The investigator will document the items that are required to evaluate the study in the subject files. Data required according to this protocol are to be recorded on the case report forms provided by the sponsor as soon as possible.
- Conditions
- Venous Thrombosis
- Being tested
- [18F]GP1 positron emission tomography/computed tomography
- Keywords
- Positron-Emission Tomography, Ultrasonography, Platelet Activation, Data Accuracy
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]GP1 positron emission tomography/computed tomographyDrug
A radioactive dose of 250 MBq of the study drug with a total quantity of ≤ 10 µg will be administered as slow intravenous bolus injection over up to 60 seconds. PET/CT examinations will be performed at 120 ± 15 min after the administration of [18F]GP1.
| Study group | Role | What they receive |
|---|---|---|
| Deep vein thrombosis | Experimental | Subjects with Deep vein thrombosis will receive a single IV injection of [18F] GP1 Receives: Drug: [18F]GP1 positron emission tomography/computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of qualitative [18F]GP1 PET/CT interpretation for the diagnosis of patients with acute proximal deep vein thrombosis
Sensitivity = (the number of [18F]GP1 PET/CT-positive patients divided by the number of ultrasonography-positive patients) x 100; specificity = (the number of [18F]GP1 PET/CT-negative patients divided by the number of ultrasonography-negative patients) x 100.
Measured: within 7 days of [18F]GP1 PET/CT
Secondary outcomes (12)
Area under the receiver operating characteristic curve, sensitivity and specificity of quantitative [18F]GP1 PET/CT interpretation for the diagnosis of patients with acute proximal deep vein thrombosis
Area under the receiver operating characteristic curve. Sensitivity = (the number of [18F]GP1 PET/CT-positive patients divided by the number of ultrasonography-positive patients) x 100; specificity = (the number of [18F]GP1 PET/CT-negative patients divided by the number of ultrasonography-negative patients) x 100.
Measured: Within 7 days of [18F]GP1 PET/CT
Positive and negative percent agreement between qualitative [18F]GP1 PET/CT and ultrasonography interpretation for the diagnosis of patients with acute distal deep vein thrombosis
Positive percent agreement = (the number of [18F]GP1 PET/CT-positive patients divided by the number of ultrasonography-positive patients) x 100; negative percent agreement = (the number of [18F]GP1 PET/CT-negative patients divided by the number of ultrasonography-negative patients) x 100
Measured: Within 7 days of [18F]GP1 PET/CT
Positive and negative percent agreement between quantitative [18F]GP1 PET/CT and ultrasonography interpretation for the diagnosis of patients with acute distal deep vein thrombosis
Positive percent agreement = (the number of [18F]GP1 PET/CT-positive patients divided by the number of ultrasonography-positive patients) x 100; negative percent agreement = (the number of [18F]GP1 PET/CT-negative patients divided by the number of ultrasonography-negative patients) x 100
Measured: Within 7 days of [18F]GP1 PET/CT
Intra- and inter-reader variability of qualitative [18F]GP1 PET/CT interpretation for the assessment of acute proximal and distal deep vein thrombosis
kappa statistic
Measured: Within 1 day of [18F]GP1 PET/CT
Detection rate of pulmonary embolism with [18F]GP1 PET/CT
The number of [18F]GP1 PET/CT-positive patients divided by the number of ultrasonography-positive patients) x 100; negative percent agreement = (the number of all patients who underwent [18F]GP1 PET/CT
Measured: Within 1 day of [18F]GP1 PET/CT
Percent fraction of unmetabolized [18F]GP1 in plasma
Percentage
Measured: Within 1 day of [18F]GP1 PET/CT
Incidence of treatment emergent adverse events
Number of participants with treatment emergent adverse events graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
Measured: From the administration of [18F]GP1 to one day after [18F]GP1 PET/CT
Blood pressure
mmHg
Measured: Pre-treatment and three hours after the administration of [18F]GP1
Heart rate
beats/minute
Measured: Pre-treatment and three hours after the administration of [18F]GP1
Body temperature
Celsius
Measured: Pre-treatment and three hours after the administration of [18F]GP1
Physical examination
The limited physical examination will comprise: general appearance, skin, neck, lungs, heart, abdomen, and a limited neurological examination (mental status, motor strength and sensor perception).
Measured: Pre-treatment and three hours after the administration of [18F]GP1
Blood tests for safety
The clinical laboratory safety parameters to be assessed are as follows: glutamate pyruvate transaminase, glutamate-oxaloacetate transaminase, alkaline phosphatase, total bilirubin, creatinine, potassium, sodium, total protein, blood urea nitrogen, albumin.
Measured: Pre-treatment and three hours after the administration of [18F]GP1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start13 Jan 2020
- Primary completion13 Aug 2025
- Study completion13 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Venous ThrombosisStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Symptomatic subjects with a pretest score of deep vein thrombosis likely (Wells score ≥ 2) or a positive D-dimer test will receive \[18F\]GP1 PET/CT.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dae Hyuk Moon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dae Hyuk Moon, Asan Medical Center
- Investigators
- Dae Hyuk Moon, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156230
- Sponsor's protocol ID
- GP1-1901
- Status last verified
- Aug 2025
- First submitted
- 4 Nov 2019
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lohrke J, Siebeneicher H, Berger M, Reinhardt M, Berndt M, Mueller A, Zerna M, Koglin N, Oden F, Bauser M, Friebe M, Dinkelborg LM, Huetter J, Stephens AW. 18F-GP1, a Novel PET Tracer Designed for High-Sensitivity, Low-Background Detection of Thrombi. J Nucl Med. 2017 Jul;58(7):1094-1099. doi: 10.2967/jnumed.116.188896. Epub 2017 Mar 16.
PubMed 28302764Kim C, Lee JS, Han Y, Chae SY, Jin S, Sung C, Son HJ, Oh SJ, Lee SJ, Oh JS, Cho YP, Kwon TW, Lee DH, Jang S, Kim B, Koglin N, Berndt M, Stephens AW, Moon DH. Glycoprotein IIb/IIIa receptor imaging with 18F-GP1 positron emission tomography for acute venous thromboembolism: an open-label, non-randomized, first-in-human phase 1 study. J Nucl Med. 2018 Jun 29;60(2):244-9. doi: 10.2967/jnumed.118.212084. Online ahead of print.
PubMed 29959214Chae 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 30617563Lee N, Oh I, Chae SY, Jin S, Oh SJ, Lee SJ, Koglin N, Berndt M, Stephens AW, Oh JS, Moon DH. Radiation dosimetry of [18F]GP1 for imaging activated glycoprotein IIb/IIIa receptors with positron emission tomography in patients with acute thromboembolism. Nucl Med Biol. 2019 May-Jun;72-73:45-48. doi: 10.1016/j.nucmedbio.2019.07.003. Epub 2019 Jul 10.
PubMed 31330411
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Non-randomized, Single Center Study to Assess Diagnostic Validity of [18F]GP1 Positron Emission Tomography/Computed Tomography for Acute Deep Vein Thrombosis of the Lower Extremities in Symptomatic Patients
- ClinicalTrials.gov ID
- NCT04156230
- Acronym / sponsor ID
- GP1-1901
- Conditions
- Venous Thrombosis
- Keywords
- Positron-Emission Tomography, Ultrasonography, Platelet Activation, Data Accuracy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Dae Hyuk MoonUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 7 Nov 2019 (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.
The first-in-human study of [18F]GP1 positron emission tomography/computed tomography (PET/CT) showed that [18F]GP1 is safe and promising novel PET tracer for imaging acute venous thromboembolism with favorable biodistribution and pharmacokinetics in patients. The goal of this phase 2 study is to evaluate whether [18F]GP1 PET/CT is sensitive and specific for the diagnosis of acute deep vein thrombosis in the appropriate patient population and clinical setting. This study will provide preliminary evidence of efficacy and expand the safety database in a larger group of patients who were suspected of having acute deep vein thrombosis. This study will further optimize image acquisition techniques, and develop methods and criteria by which [18F]GP1 PET/CT will be evaluated. Other critical questions about [18F]GP1 biodistribution including [18F]GP1 uptake in pulmonary and systemic arteries will be evaluated.
Detailed description
This study is an open label, non-randomized, single center, intervention study. An estimated 63 symptomatic subjects with a pretest score of deep vein thrombosis likely (Wells score ≥ 2) or a positive D-dimer test will receive [18F]GP1 PET/CT to evaluate the diagnostic validity of [18F]GP1 PET/CT for detecting deep vein thrombosis foci in lower extremities.
The study comprises 3 periods: screening, treatment, and follow-up. The screening period starts with the patient's signature on the informed consent form and ends with assignment to treatment that is inclusion of the subject for treatment. The treatment period starts with baseline measurements, and ends with the last measurement/procedure on the day of intravenous injection of 250 MBq of [18F]GP1. The follow-up period contains the end-of-study interview. Key measurement is the PET/CT image acquisition about 120 minutes after the single injection of [18F]GP1 This study includes venous ultrasonography of deep vein thrombosis as a valid reference standard. [18F]GP1 PET/CT will be assessed qualitatively and quantitatively by three experienced readers.
This study will be monitored regularly by a clinical research associate from the sponsor or a designated contract research organization. Data quality and study integrity will be assessed. The investigator will document the items that are required to evaluate the study in the subject files. Data required according to this protocol are to be recorded on the case report forms provided by the sponsor as soon as possible.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Symptomatic subjects with a pretest score of deep vein thrombosis likely (Wells score ≥ 2) or a positive D-dimer test will receive [18F]GP1 PET/CT.
| Arm | Type | Receives |
|---|---|---|
| Deep vein thrombosis | Experimental | Drug: [18F]GP1 positron emission tomography/computed tomographySubjects with Deep vein thrombosis will receive a single IV injection of [18F] GP1 |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A subject will be enrolled if he/she meets all of the following inclusion criteria.
Key exclusion criteria (14 listed)
- A subject is to be excluded from the study if he/she does not fulfill the inclusion criteria or display any of the following criteria.
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]GP1 positron emission tomography/computed tomographyA radioactive dose of 250 MBq of the study drug with a total quantity of ≤ 10 µg will be administered as slow intravenous bolus injection over up to 60 seconds. PET/CT examinations will be performed at 120 ± 15 min after the administration of [18F]GP1. | Drug | Deep vein thrombosis |
Primary outcome
Sensitivity and specificity of qualitative [18F]GP1 PET/CT interpretation for the diagnosis of patients with acute proximal deep vein thrombosis
Time frame: within 7 days of [18F]GP1 PET/CT
Sensitivity = (the number of [18F]GP1 PET/CT-positive patients divided by the number of ultrasonography-positive patients) x 100; specificity = (the number of [18F]GP1 PET/CT-negative patients divided by the number of ultrasonography-negative patients) x 100.
12 secondary outcomes
Area under the receiver operating characteristic curve, sensitivity and specificity of quantitative [18F]GP1 PET/CT interpretation for the diagnosis of patients with acute proximal deep vein thrombosis
Time frame: Within 7 days of [18F]GP1 PET/CT
Positive and negative percent agreement between qualitative [18F]GP1 PET/CT and ultrasonography interpretation for the diagnosis of patients with acute distal deep vein thrombosis
Time frame: Within 7 days of [18F]GP1 PET/CT
Positive and negative percent agreement between quantitative [18F]GP1 PET/CT and ultrasonography interpretation for the diagnosis of patients with acute distal deep vein thrombosis
Time frame: Within 7 days of [18F]GP1 PET/CT
Intra- and inter-reader variability of qualitative [18F]GP1 PET/CT interpretation for the assessment of acute proximal and distal deep vein thrombosis
Time frame: Within 1 day of [18F]GP1 PET/CT
Detection rate of pulmonary embolism with [18F]GP1 PET/CT
Time frame: Within 1 day of [18F]GP1 PET/CT
Percent fraction of unmetabolized [18F]GP1 in plasma
Time frame: Within 1 day of [18F]GP1 PET/CT
Incidence of treatment emergent adverse events
Time frame: From the administration of [18F]GP1 to one day after [18F]GP1 PET/CT
Blood pressure
Time frame: Pre-treatment and three hours after the administration of [18F]GP1
Heart rate
Time frame: Pre-treatment and three hours after the administration of [18F]GP1
Body temperature
Time frame: Pre-treatment and three hours after the administration of [18F]GP1
Physical examination
Time frame: Pre-treatment and three hours after the administration of [18F]GP1
Blood tests for safety
Time frame: Pre-treatment and three hours after the administration of [18F]GP1
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 24 Aug 2025.
- Background: PubMed 28302764Lohrke J, Siebeneicher H, Berger M, Reinhardt M, Berndt M, Mueller A, Zerna M, Koglin N, Oden F, Bauser M, Friebe M, Dinkelborg LM, Huetter J, Stephens AW. 18F-GP1, a Novel PET Tracer Designed for High-Sensitivity, Low-Background Detection of Thrombi. J Nucl Med. 2017 Jul;58(7):1094-1099. doi: 10.2967/jnumed.116.188896. Epub 2017 Mar 16.
- Background: PubMed 29959214Kim C, Lee JS, Han Y, Chae SY, Jin S, Sung C, Son HJ, Oh SJ, Lee SJ, Oh JS, Cho YP, Kwon TW, Lee DH, Jang S, Kim B, Koglin N, Berndt M, Stephens AW, Moon DH. Glycoprotein IIb/IIIa receptor imaging with 18F-GP1 positron emission tomography for acute venous thromboembolism: an open-label, non-randomized, first-in-human phase 1 study. J Nucl Med. 2018 Jun 29;60(2):244-9. doi: 10.2967/jnumed.118.212084. Online ahead of print.
- Background: 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.
- Background: PubMed 31330411Lee N, Oh I, Chae SY, Jin S, Oh SJ, Lee SJ, Koglin N, Berndt M, Stephens AW, Oh JS, Moon DH. Radiation dosimetry of [18F]GP1 for imaging activated glycoprotein IIb/IIIa receptors with positron emission tomography in patients with acute thromboembolism. Nucl Med Biol. 2019 May-Jun;72-73:45-48. doi: 10.1016/j.nucmedbio.2019.07.003. Epub 2019 Jul 10.
- 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.
Dae Hyuk Moon, MD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [18F]GP1 positron emission tomography/computed tomography in people with Venous Thrombosis, run by Dae Hyuk Moon 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 6 inclusion and 14 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 24 Aug 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Sensitivity and specificity of qualitative [18F]GP1 PET/CT interpretation for the diagnosis of patients with acute proximal deep vein thrombosis (time frame: within 7 days of [18F]GP1 PET/CT). 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 NCT04156230, which also lists 4 linked publications.
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 24 Aug 2025.