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Safety, Pharmacokinetics, Biodistribution, and Diagnostic Performance of [18F]GP1 PET in Thromboembolism

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ClinicalTrials.gov Identifier: NCT02864810
Recruitment Status : Completed
First Posted : August 12, 2016
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Asan Foundation

Tracking Information
First Submitted Date  ICMJE August 3, 2016
First Posted Date  ICMJE August 12, 2016
Last Update Posted Date May 18, 2018
Actual Study Start Date  ICMJE August 4, 2016
Actual Primary Completion Date September 9, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2016)
Detection rate of thromboembolic focus/foci with [18F]GP1 PET/CT [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2016)
  • 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 ]
    Evaluation of safety of [18F]GP1
  • Correlation of [18F]GP1 activity with fibrinogen and platelet glycoprotein IIb/IIIa and P-selectin expression. [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Pharmacokinetics, Biodistribution, and Diagnostic Performance of [18F]GP1 PET in Thromboembolism
Official Title  ICMJE 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
Brief 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. Safety, pharmacokinetics, biodistribution, internal radiation dosimetry and diagnostic performance of [18F]GP1 will be assessed in all subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Thromboembolism
Intervention  ICMJE Drug: [18F]GP1
[18F]GP1 PET/CT imaging for detecting thromboembolism
Other Name: GP1
Study Arms  ICMJE Experimental: [18F]GP1 PET/CT imaging

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

Intervention: Drug: [18F]GP1
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 (18)F-GP1 positron emission tomography for imaging acute arterial thrombosis. EJNMMI Res. 2019 Jan 7;9(1):3. doi: 10.1186/s13550-018-0471-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2018)
32
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2016)
30
Actual Study Completion Date  ICMJE September 9, 2017
Actual Primary Completion Date September 9, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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;
    • 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

Exclusion Criteria:

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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02864810
Other Study ID Numbers  ICMJE GP1-1501
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Asan Foundation
Study Sponsor  ICMJE Asan Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Asan Foundation
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP