Diagnostic Validity of [18F]GP1 PET for Diagnosing Acute Deep Vein Thrombosis

NCT04156230 | Completed Phase 2

• 1 other identifier: GP1-1901
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Venous Thrombosis

Keywords

Positron-Emission Tomography; Ultrasonography; Platelet Activation; Data Accuracy

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  Within 1 day of [18F]GP1 PET/CT

• Detection rate of pulmonary embolism with [18F]GP1 PET/CT

  Within 1 day of [18F]GP1 PET/CT

Study Arms (1)

Deep vein thrombosis

EXPERIMENTAL

Subjects with Deep vein thrombosis will receive a single IV injection of \[18F\] GP1

Drug: [18F]GP1 positron emission tomography/computed tomography

Interventions

[18F]GP1 positron emission tomography/computed tomography DRUG

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.

Deep vein thrombosis

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Anticancer chemotherapy is scheduled to be given to subject before or within 24 hours after administration of \[18F\]GP1.
• 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.

Sponsors & Collaborators

• Dae Hyuk Moon: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (4)

• 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.

  PMID: 28302764 BACKGROUND

• Kim 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.

  PMID: 29959214 BACKGROUND

• 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 BACKGROUND

• Lee 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.

  PMID: 31330411 BACKGROUND

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dae Hyuk Moon, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 7, 2019
• Study Start: January 13, 2020
• Primary Completion: August 13, 2025
• Study Completion: August 13, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)