NCT02640313: PARISK

Molecular Imaging of Plaque Vulnerability Using 18F-choline PET-MRI in Carotid Artery Atherosclerosis Patients

Status unknown Phase 3 Last updated 23 October 2023

What this trial tests

Phase 3 trial testing 18F-choline PET-MR imaging in Plaque, Atherosclerotic in 14 participants. Status unknown.

Timeline

1 December 2015

Primary endpoint
1 March 2024

1 March 2024

Quick facts

Lead sponsor	Maastricht University Medical Center
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	14
Start date	1 December 2015
Primary completion	1 March 2024
Estimated completion	1 March 2024
Sites	1 location across Netherlands

Drugs / interventions tested

• 18F-choline PET-MR imaging — full drug profile →

Conditions studied

• Plaque, Atherosclerotic — all drugs for Plaque, Atherosclerotic →

Sponsor

Maastricht University Medical Center

Who can join

18 and older, any sex, with Plaque, Atherosclerotic. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 18F-choline uptake, as marker of plaque inflammation
  Time frame: 1 year
  • To assess on PET the uptake of 18F-choline tracer in the symptomatic carotid artery plaque, given as Target-to-Background uptake Ratio (TBR);
• correlate the intra-plaque uptake of 18F-choline on PET with the total area of CD68-positivity within the symptomatic plaque
  Time frame: 1 year
  • In case of carotid surgery, to correlate the intra-plaque uptake of 18F-choline on PET with the total area of CD68-positivity within the symptomatic plaque, as a measure of plaque inflammation and vulnerability on histology
• sensitivity, specificity, negative predictive value of 18F-choline PET
  Time frame: 1 year
  • To determine the sensitivity, specificity, negative predictive value of 18F-choline PET in diagnosis of vulnerable plaques.

Sponsor's own description

Accumulating data in the literature suggests that radiolabeled-choline (18F-choline) is a sensitive molecular tracer for PET imaging that is taken up in activated cells and, as such, is able to identify active inflammatory sites. The investigators hypothesize that 18F-choline is also highly taken up in vulnerable plaques in comparison to the stable ones.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Non-invasive imaging of the coronary arteries.
   Adamson PD, Newby DE. · · 2019 · cited 29× · PMID 30388261 · DOI 10.1093/eurheartj/ehy670
2. "Vascular inflammation and cardiovascular disease: review about the role of PET imaging".
   Sammartino AM, Falco R, Drera A, Dondi F, et al · · 2023 · cited 16× · PMID 36255543 · DOI 10.1007/s10554-022-02730-9
3. An Update on [¹⁸F]Fluoride PET Imaging for Atherosclerotic Disease.
   Lee R, Seok JW. · · 2020 · cited 8× · PMID 33024730 · DOI 10.12997/jla.2020.9.3.349
4. Quantification of carotid plaque composition with a multi-contrast atherosclerosis characterization (MATCH) MRI sequence.
   Kassem M, Nies KPH, Boswijk E, van der Pol J, et al · · 2023 · cited 3× · PMID 37680565 · DOI 10.3389/fcvm.2023.1227495
5. Advances in Radiopharmaceutical Sciences for Vascular Inflammation Imaging: Focus on Clinical Applications.
   Prigent K, Vigne J. · · 2021 · cited 3× · PMID 34885690 · DOI 10.3390/molecules26237111