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NCT02607748
18F-fluoride (18F-NaF) PET for Identifying Coronary Atherosclerotic Plaques
Phase 4 trial testing 18F-NaF PET and coronary CTA imaging in Coronary Artery Disease in 41 participants. Completed in 31 August 2021.
31 August 2021
Quick facts
| Lead sponsor | Cedars-Sinai Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 41 |
| Start date | 13 November 2015 |
| Primary completion | 31 August 2021 |
| Estimated completion | 31 August 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- 18F-NaF PET and coronary CTA imaging
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Atherosclerotic Plaque — all drugs for Atherosclerotic Plaque →
Sponsor
Cedars-Sinai Medical Center
Who can join
18 and older, any sex, with Coronary Artery Disease or Atherosclerotic Plaque. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate whether 18F-NaF (sodium fluoride) Positron Emission Tomography (PET) scans can be used to identify ruptured and high-risk plaque as compared to non-invasive coronary Computed Tomography Angiography (CTA) scans and high-definition intravascular ultrasound (IVUS). In subsets of patients, 18F-NaF PET scans and CCTA will be repeated to assess scan-rescan reproducibility.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Coronary <sup>18</sup>F-Sodium Fluoride Uptake Predicts Outcomes in Patients With Coronary Artery Disease.
Kwiecinski J, Tzolos E, Adamson PD, Cadet S, et al · · 2020 · cited 125× · PMID 32553260 · DOI 10.1016/j.jacc.2020.04.046 -
Machine Learning with <sup>18</sup>F-Sodium Fluoride PET and Quantitative Plaque Analysis on CT Angiography for the Future Risk of Myocardial Infarction.
Kwiecinski J, Tzolos E, Meah MN, Cadet S, et al · · 2022 · cited 47× · PMID 33893193 · DOI 10.2967/jnumed.121.262283 -
Bypass Grafting and Native Coronary Artery Disease Activity.
Kwiecinski J, Tzolos E, Fletcher AJ, Nash J, et al · · 2022 · cited 38× · PMID 35216930 · DOI 10.1016/j.jcmg.2021.11.030 -
Latent Coronary Plaque Morphology From Computed Tomography Angiography, Molecular Disease Activity on Positron Emission Tomography, and Clinical Outcomes.
Kwiecinski J, Kolossváry M, Tzolos E, Meah MN, et al · · 2023 · cited 11× · PMID 37165878 · DOI 10.1161/atvbaha.123.319332 -
Sex differences in coronary atherosclerotic plaque activity using <sup>18</sup>F-sodium fluoride positron emission tomography.
Kwiecinski J, Wang KL, Tzolos E, Moss A, et al · · 2024 · cited 6× · PMID 38926161 · DOI 10.1007/s00259-024-06810-x
Verify or expand the search:
- PubMed search for NCT02607748
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02607748 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cedars-Sinai Medical Center
- Last refreshed: 22 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02607748.
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