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

NCT02864810 | Completed Phase 1

• 1 other identifier: GP1-1501
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Thromboembolism

Outcome Measures

Primary Outcomes (1)

• Detection rate of thromboembolic focus/foci with [18F]GP1 PET/CT

  6 months

Secondary Outcomes (9)

• 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

Study Arms (1)

[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

Drug: [18F]GP1

Interventions

[18F]GP1 DRUG

\[18F\]GP1 PET/CT imaging for detecting thromboembolism

Also known as: GP1

[18F]GP1 PET/CT imaging

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Foundation: lead

Study Sites (1)

Asan Foundation

Seoul, 05505, South Korea

Location

Related Publications (1)

• 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.

  PMID: 30617563 DERIVED

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 12, 2016
• Study Start: August 4, 2016
• Primary Completion: September 9, 2017
• Study Completion: September 9, 2017
• Last Updated: May 18, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)