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Diagnostic Validity of [18F]GP1 PET for the Assessment of Deep Vein Thrombosis

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ClinicalTrials.gov Identifier: NCT04156230
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Dae Hyuk Moon, Asan Medical Center

Brief Summary:

The first-in-human study of [18F]GP1 PET/CT showed that [18F]GP1 is safe and promising novel PET tracer for imaging acute venous thromboembolism (VTE) with favorable biodistribution and pharmacokinetics in patients. By using [18F]GP1, which targets an intrinsic pathologic molecular event in thrombus formation, it is possible to detect acute VTE within the whole body without contrast medium. [18F]GP1 PET/CT may identify thrombi in distal veins of the leg, where conventional imaging has limitations.

Venous ultrasonography (VUS) is the first line imaging modality for the evaluation of suspected first lower extremity deep vein thrombosis (DVT). VUS is now established as a definitive diagnostic test for DVT. Diagnosis of acute proximal DVT of the leg by VUS justifies anticoagulation. However, for the diagnosis of distal DVT, VUS approaches generate a larger number of false-negative results. It is still controversial whether VUS-diagnosed distal DVT is anticoagulated. In this study, diagnostic validity of [18F]GP1 PET/CT for the diagnosis of patients with acute proximal DVT will be determined


Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Drug: [18F]GP1 Phase 2

Detailed Description:

The first-in-human study of [18F]GP1 PET/CT showed that [18F]GP1 is safe and promising novel PET tracer for imaging acute venous thromboembolism (VTE) with favorable biodistribution and pharmacokinetics in patients. By using [18F]GP1, which targets an intrinsic pathologic molecular event in thrombus formation, it is possible to detect acute VTE within the whole body without contrast medium. [18F]GP1 PET/CT may identify thrombi in distal veins of the leg, where conventional imaging has limitations.

Venous ultrasonography (VUS) is the first line imaging modality for the evaluation of suspected first lower extremity deep vein thrombosis (DVT). VUS is now established as a definitive diagnostic test for DVT. Diagnosis of acute proximal DVT of the leg by VUS justifies anticoagulation. However, for the diagnosis of distal DVT, VUS approaches generate a larger number of false-negative results. It is still controversial whether VUS-diagnosed distal DVT is anticoagulated. In this study, diagnostic validity of [18F]GP1 PET/CT for the diagnosis of patients with acute proximal DVT will be determined


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Deep vein thrombosis
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Estimated Study Start Date : November 11, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Deep vein thrombosis
Subjects with Deep vein thrombosis will receive a single IV injection of [18F] GP1
Drug: [18F]GP1

Maximally 70 subjects with Deep vein thrombosis(up to 22 DVT and 22 Non-DVT subjects) will be enrolled in the study (plus replacements for drop-outs).

Intravenous injection of [18F]GP1 and PET/CT scanning

Other Name: GP1




Primary Outcome Measures :
  1. Sensitivity and specificity of qualitative [18F]GP1 Positron emission tomography/Computed tomography interpretation for the diagnosis of patients with acute proximal Deep vein thrombosis [ Time Frame: 120 ~ 140 minutes post injection ]
    Sensitivity and specificity of qualitative [18F]GP1 Positron emission tomography/Computed tomography interpretation for the diagnosis of patients with acute proximal Deep vein thrombosis Intravenous injection of [18F]GP1 and Positron emission tomography/Computed tomography scanning


Secondary Outcome Measures :
  1. Area under the receiver operating characteristic curve, sensitivity and specificity of quantitative [18F]GP1 Positron emission tomography/Computed tomography interpretation for the diagnosis of patients with acute proximal Deep vein thrombosis [ Time Frame: 120 ~ 140 minutes post injection ]
    Area under the receiver operating characteristic curve, sensitivity and specificity of quantitative [18F]GP1 Positron emission tomography/Computed tomography interpretation for the diagnosis of patients with acute proximal Deep vein thrombosis

  2. Positive and negative percent agreement between qualitative [18F]GP1 Positron emission tomography/Computed tomography and Venous ultrasonography interpretation for the diagnosis of patients with acute distal Deep vein thrombosis [ Time Frame: 120 ~ 140 minutes post injection ]
    Positive and negative percent agreement between qualitative [18F]GP1 Positron emission tomography/Computed tomography and Venous ultrasonography interpretation for the diagnosis of patients with acute distal Deep vein thrombosis

  3. Positive and negative percent agreement between quantitative [18F]GP1 Positron emission tomography/Computed tomography and Venous ultrasonography interpretation for the diagnosis of patients with acute distal Deep vein thrombosis [ Time Frame: 120 ~ 140 minutes post injection ]
    Positive and negative percent agreement between quantitative [18F]GP1 Positron emission tomography/Computed tomography and Venous ultrasonography interpretation for the diagnosis of patients with acute distal Deep vein thrombosis



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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 DVT of the lower extremity within 14 days prior to the planned [18F]GP1 PET/CT.
    • The pretest probability for DVT is likely by two-level Wells score (≥ 2), or the D-dimer test is positive.
    • Subject underwent or is scheduled to undergo VUS within 7 days of [18F]GP1 PET/CT:
    • Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at time of screening.

Exclusion Criteria:

  • 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 DVT or PE.
    • Subject has symptoms of acute DVT 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.
    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156230


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Dae Hyuk Moon

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Responsible Party: Dae Hyuk Moon, Principal Investigator, Asan Medical Center
ClinicalTrials.gov Identifier: NCT04156230     History of Changes
Other Study ID Numbers: GP1-19001
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases