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

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.

Study Overview

• Status: Completed
• Conditions: Thromboembolism
• Intervention / Treatment: Drug: [18F]GP1

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: [18F]GP1; [18F]GP1 PET/CT imaging for detecting thromboembolism; Other Names: GP1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Detection rate of thromboembolic focus/foci with [18F]GP1 PET/CT	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative assessment of [18F]GP1 uptake in thromboembolic focus/foci as measured by standardized uptake value (SUV)		6 months
Biodistribution and radiation dosimetry of [18F]GP1 as measured by SUV		6 months
Biodistribution and radiation dosimetry of [18F]GP1 as measured by radiation doses per organ (μGy/MBq).		6 months
Pharmacokinetics of [18F]GP1 as measured by area under the curve		6 months
Pharmacokinetics of [18F]GP1 as measured by Cmax		6 months
Pharmacokinetics of [18F]GP1 as measured by Tmax		6 months
Pharmacokinetics of [18F]GP1 as measured by percent fraction		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	6 months
Correlation of [18F]GP1 activity with fibrinogen and platelet glycoprotein IIb/IIIa and P-selectin expression.		6 months

Collaborators and Investigators

• Sponsor: Asan Foundation

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2016
• Primary Completion (Actual): September 9, 2017
• Study Completion (Actual): September 9, 2017

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (Estimate): August 12, 2016

Study Record Updates

• Last Update Posted (Actual): May 18, 2018
• Last Update Submitted That Met QC Criteria: May 16, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism
• Other Study ID Numbers: GP1-1501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No