Assessing Inflammatory Plaques in Carotid Arteries Using Advanced Imaging
Multimodal Assessment of the Inflammatory Atheromatous Plaque : Comparison Between 68Ga-NODAGA-RGD PET/CT, 18F-FDG PET/CT, MRI AND US
This study is testing a new imaging method to see if it can better detect inflammation in plaques in the carotid arteries of patients who are about to have surgery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Lausanne Hospitals Academic / other |
| Locations | 1 site (Lausanne, Canton of Vaud) |
| Trial ID | NCT01608516 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of 68Ga-NODAGA-RGD PET/CT in detecting inflammatory atheromatous plaques in patients scheduled for carotid endarterectomy. Patients will undergo both 18F-FDG PET/CT and carotid ultrasound prior to surgery, followed by 68Ga-NODAGA-RGD PET/CT and MRI the day before the procedure. The results from these imaging techniques will be compared against histopathological samples to determine the level of plaque inflammation. The goal is to identify which imaging method provides the most accurate assessment of plaque inflammation.
Who should consider this trial
Good fit: Ideal candidates are patients aged 85 or younger who are scheduled for carotid endarterectomy and have a Karnofsky performance score of 80 or higher.
Not a fit: Patients with contraindications to surgery, MRI, or gadolinium injection, as well as those who are pregnant or breastfeeding, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic techniques for assessing carotid artery diseases, potentially enhancing patient outcomes.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for similar assessments, but the specific use of 68Ga-NODAGA-RGD PET/CT in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \<= 85 years * Karnofsky \>= 80% * patient with indication ofr carotid endarterectomy * signed consent form Exclusion Criteria: * indication for surgery other than endarterectomy \<14 days * contraindication to surgery * contraindication to MRI * contraindication to gadolinium injection (stage 4/5 kidney insufficiency, GFR\<30ml/min/1.73m2) * pregnancy, breastfeeding * lack of discernment
Where this trial is running
Lausanne, Canton of Vaud
- Centre Hospitalier Universitaire Vaudois — Lausanne, Canton of Vaud, Switzerland (Recruiting)
Study contacts
- Principal investigator: John O. Prior, PhD, MD — Lausanne University Hospitals
- Study coordinator: John O. Prior, PhD, MD
- Email: john.prior@chuv.ch
- Phone: +41 21 314 43 48
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.