18F-GP1 PET-CT to Detect Bioprosthetic Aortic Valve Thrombosis

NCT04073875 | Completed

• 1 other identifier: E181981
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

18F-GP1 binds with high affinity to the glycoprotein IIb/IIIa receptors on activated platelets. 18F-GP1 PET-CT has recently demonstrated favourable safety, pharmacokinetic, biodistribution and diagnostic performance for the in vivo identification of venous and arterial thrombemboli.

Conditions

Thrombosis Cardiac; Aortic Valve Disease

Outcome Measures

Primary Outcomes (2)

• Prevalence of 18F-GP1 PET-CT bioprosthetic aortic valve uptake

  Prevalence of 18F-GP1 PET-CT bioprosthetic aortic valve uptake as measured by standardised uptake values.

  2 years

• Intensity of 18F-GP1 PET-CT activity in bioprosthetic aortic valve thrombus

  Intensity of 18F-GP1 PET-CT activity in bioprosthetic aortic valve thrombus compared to blood pool as measured by standardised uptake values.

  2 years

Secondary Outcomes (1)

• 18F-GP1 PET-CT bioprosthetic aortic valve uptake in patients with thrombus.

  2 years

Study Arms (2)

Bioprosthetic aortic valve

Single 18F-GP1 PET-CT

Diagnostic Test: 18F-GP1

Bioprosthetic aortic valve thrombus - repeat imaging

18F-GP1 PET-CT at baseline and 3 months

Diagnostic Test: 18F-GP1

Interventions

18F-GP1 DIAGNOSTIC_TEST

18F-GP1 PET-CT scan

Bioprosthetic aortic valve; Bioprosthetic aortic valve thrombus - repeat imaging

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients \>1 month post-bioprosthetic aortic valve replacement.

You may qualify if:

• ability to give informed consent
• \>1 month post-surgical or transcatheter aortic valve replacement

You may not qualify if:

• Inability to give informed consent
• Pregnancy or breastfeeding
• Contraindications to iodinated contrast
• Contraindications to anticoagulation
• Use of anticoagulants during the post-operative period prior to screening
• Extreme claustrophobia
• Chronic kidney disease (with estimated glomerular filtration rate \<30 mL/min/1.73m2)
• Metastatic malignancy
• Inability to tolerate the supine position

Sponsors & Collaborators

• University of Edinburgh: lead
• Life Molecular Imaging SA: collaborator
• British Heart Foundation: collaborator

Study Sites (1)

University of Edinburgh

Edinburgh, United Kingdom

Location

Related Publications (10)

• 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

• Durko AP, Osnabrugge RL, Van Mieghem NM, Milojevic M, Mylotte D, Nkomo VT, Pieter Kappetein A. Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections. Eur Heart J. 2018 Jul 21;39(28):2635-2642. doi: 10.1093/eurheartj/ehy107.

  PMID: 29546396 BACKGROUND

• Johnston DR, Soltesz EG, Vakil N, Rajeswaran J, Roselli EE, Sabik JF 3rd, Smedira NG, Svensson LG, Lytle BW, Blackstone EH. Long-term durability of bioprosthetic aortic valves: implications from 12,569 implants. Ann Thorac Surg. 2015 Apr;99(4):1239-47. doi: 10.1016/j.athoracsur.2014.10.070. Epub 2015 Feb 4.

  PMID: 25662439 BACKGROUND

• Rodriguez-Gabella T, Voisine P, Puri R, Pibarot P, Rodes-Cabau J. Aortic Bioprosthetic Valve Durability: Incidence, Mechanisms, Predictors, and Management of Surgical and Transcatheter Valve Degeneration. J Am Coll Cardiol. 2017 Aug 22;70(8):1013-1028. doi: 10.1016/j.jacc.2017.07.715.

  PMID: 28818190 BACKGROUND

• Chakravarty T, Sondergaard L, Friedman J, De Backer O, Berman D, Kofoed KF, Jilaihawi H, Shiota T, Abramowitz Y, Jorgensen TH, Rami T, Israr S, Fontana G, de Knegt M, Fuchs A, Lyden P, Trento A, Bhatt DL, Leon MB, Makkar RR; RESOLVE; SAVORY Investigators. Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study. Lancet. 2017 Jun 17;389(10087):2383-2392. doi: 10.1016/S0140-6736(17)30757-2. Epub 2017 Mar 19.

  PMID: 28330690 BACKGROUND

• Makkar RR, Fontana G, Jilaihawi H, Chakravarty T, Kofoed KF, De Backer O, Asch FM, Ruiz CE, Olsen NT, Trento A, Friedman J, Berman D, Cheng W, Kashif M, Jelnin V, Kliger CA, Guo H, Pichard AD, Weissman NJ, Kapadia S, Manasse E, Bhatt DL, Leon MB, Sondergaard L. Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. N Engl J Med. 2015 Nov 19;373(21):2015-24. doi: 10.1056/NEJMoa1509233. Epub 2015 Oct 5.

  PMID: 26436963 BACKGROUND

• Bing R, Deutsch MA, Sellers SL, Corral CA, Andrews JPM, van Beek EJR, Bleiziffer S, Burchert W, Clark T, Dey D, Friedrichs K, Gummert JF, Koglin N, Leipsic JA, Lindner O, MacAskill MG, Milting H, Pessotto R, Preuss R, Raftis JB, Rudolph TK, Rudolph V, Slomka P, Stephens AW, Tavares A, Tzolos E, Weir N, White AC, Williams MC, Zabel R, Dweck MR, Hugenberg V, Newby DE. 18F-GP1 Positron Emission Tomography and Bioprosthetic Aortic Valve Thrombus. JACC Cardiovasc Imaging. 2022 Jun;15(6):1107-1120. doi: 10.1016/j.jcmg.2021.11.015. Epub 2022 Jan 12.

  PMID: 35033495 DERIVED

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• David E Newby, MD

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 29, 2019
• Study Start: October 22, 2019
• Primary Completion: October 13, 2021
• Study Completion: October 13, 2021
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)